FLEXIBLE PAIN RELIEF GEL EXTRA STRENGTH- pain relief gel extra strength gel FLEXIBLE PAIN RELIEF ROLL-ON EXTRA STRENGTH- pain relief roll-on extra strength gel FLEXIBLE PAIN RELIEF ROLL-ON- pain relief roll-on gel FLEXIBLE PAIN RELIEF GEL- pain relief gel gel FLEXIBLE PAIN RELIEF- pain relief lotion lotion Harmony Product LLC Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ------Flexible Pain Relief

For NDC 73096-026-01 Flexible Pain Relief

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum Active ingredient Menthol 2% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2%...... Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises - sprains Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days Warnings: For external use only For NDC 73096-027-01 Flexible Pain Relief Gel

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum Active ingredient Menthol 2% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2%...... Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises - sprains Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days Warnings: For external use only

For NDC 73096-028-01 Flexible Pain Relief Extra Strength Gel Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum Active ingredient Menthol 2.5% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2.5%...... Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises - sprains Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days Warnings: For external use only

For NDC 73096-029-01 Flexible Pain Relief Roll-on Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum Active ingredient Menthol 2% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2%...... Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises - sprains Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days Warnings: For external use only

For NDC 73096-030-01 Flexible Pain Relief Extra Strength Roll-on Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum Active ingredient Menthol 2.5% Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Purpose Menthol 2.5%...... Topical Analgesic Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises - sprains Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days Warnings: For external use only

FLEXIBLE PAIN RELIEF GEL EXTRA STRENGTH pain relief gel extra strength gel

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:730 9 6 -0 28 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED 2410 mg - UNII:L7T10 EIP3A) FORM in 9 6 .4 g

Inactive Ingredients Ingredient Name Strength PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH) EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 ) ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ) CETYL ALCO HO L (UNII: 9 36 JST6 JCN) CO MFREY LEAF (UNII: DG4F8 T8 39 X) SAFFLO WER O IL (UNII: 6 5UEH26 2IS) WATER (UNII: 0 59 QF0 KO0 R) O LIVE O IL (UNII: 6 UYK2W1W1E) EDETATE SO DIUM (UNII: MP1J8 420 LU) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) CANNABIS SATIVA SEED O IL (UNII: 6 9 VJ1LPN1S) PHENO XYETHANO L (UNII: HIE49 2ZZ3T) TRO LAMINE (UNII: 9 O3K9 3S3TK) CARBO MER CO PO LYMER TYPE B (ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 8 0 9 Y72KV36 ) DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCO SAMINE SULFATE PO TASSIUM CHLO RIDE (UNII: 15VQ11I6 6 N) GLYCERIN (UNII: PDC6 A3C0 OX) HEMP (UNII: TD1MUT0 1Q7) 10 0 0 mg in 9 6 .4 g SALIX ALBA BARK (UNII: 20 5MXS71H7)

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:730 9 6 -0 28 - 1 1 in 1 CARTON 0 7/10 /20 19 0 2 NDC:730 9 6 -0 28 - 9 6 .4 g in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n 1 0 1 Pro duct

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 0 7/10 /20 19

FLEXIBLE PAIN RELIEF ROLL-ON EXTRA STRENGTH pain relief roll-on extra strength gel

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:730 9 6 -0 30 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED MENTHOL, UNSPECIFIED 2126 mg FORM - UNII:L7T10 EIP3A) FORM in 8 5.0 5 g

Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH) ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ) CO MFREY LEAF (UNII: DG4F8 T8 39 X) WATER (UNII: 0 59 QF0 KO0 R) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) CANNABIS SATIVA SEED O IL (UNII: 6 9 VJ1LPN1S) PHENO XYETHANO L (UNII: HIE49 2ZZ3T) DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCO SAMINE SULFATE PO TASSIUM CHLO RIDE (UNII: 15VQ11I6 6 N) GLYCERIN (UNII: PDC6 A3C0 OX) HEMP (UNII: TD1MUT0 1Q7) 10 0 0 mg in 8 5.0 5 g SALIX ALBA BARK (UNII: 20 5MXS71H7) EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 )

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:730 9 6 - 1 1 in 1 CARTON 0 7/10 /20 19 0 30 -0 2 NDC:730 9 6 - 8 5.0 5 g in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a 1 0 30 -0 1 Co mbinatio n Pro duct

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 0 7/10 /20 19

FLEXIBLE PAIN RELIEF ROLL-ON pain relief roll-on gel

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:730 9 6 -0 29 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED MENTHOL, UNSPECIFIED 170 1 mg FORM - UNII:L7T10 EIP3A) FORM in 8 5.0 5 g

Inactive Ingredients Ingredient Name Strength PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH) ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ) CO MFREY LEAF (UNII: DG4F8 T8 39 X) WATER (UNII: 0 59 QF0 KO0 R) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) CANNABIS SATIVA SEED O IL (UNII: 6 9 VJ1LPN1S) PHENO XYETHANO L (UNII: HIE49 2ZZ3T) DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCO SAMINE SULFATE PO TASSIUM CHLO RIDE (UNII: 15VQ11I6 6 N) GLYCERIN (UNII: PDC6 A3C0 OX) HEMP (UNII: TD1MUT0 1Q7) 50 0 mg in 8 5.0 5 g SALIX ALBA BARK (UNII: 20 5MXS71H7) EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 ) XANTHAN GUM (UNII: TTV12P4NEE)

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:730 9 6 - 1 1 in 1 CARTON 0 6 /26 /20 19 0 29 -0 2 NDC:730 9 6 - 8 5.0 5 g in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a 1 0 29 -0 1 Co mbinatio n Pro duct

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 0 6 /26 /20 19

FLEXIBLE PAIN RELIEF GEL pain relief gel gel

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:730 9 6 -0 27 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED 19 28 mg - UNII:L7T10 EIP3A) FORM in 9 6 .4 g

Inactive Ingredients Ingredient Name Strength ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ) CETYL ALCO HO L (UNII: 9 36 JST6 JCN) CO MFREY LEAF (UNII: DG4F8 T8 39 X) SAFFLO WER O IL (UNII: 6 5UEH26 2IS) WATER (UNII: 0 59 QF0 KO0 R) O LIVE O IL (UNII: 6 UYK2W1W1E) EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 ) EDETATE SO DIUM (UNII: MP1J8 420 LU) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) CANNABIS SATIVA SEED O IL (UNII: 6 9 VJ1LPN1S) PHENO XYETHANO L (UNII: HIE49 2ZZ3T) TRO LAMINE (UNII: 9 O3K9 3S3TK) PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH) CARBO MER CO PO LYMER TYPE B (ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 8 0 9 Y72KV36 ) DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCO SAMINE SULFATE PO TASSIUM CHLO RIDE (UNII: 15VQ11I6 6 N) GLYCERIN (UNII: PDC6 A3C0 OX) HEMP (UNII: TD1MUT0 1Q7) 50 0 mg in 9 6 .4 g SALIX ALBA BARK (UNII: 20 5MXS71H7)

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:730 9 6 -0 27- 1 1 in 1 CARTON 0 7/10 /20 19 0 2 NDC:730 9 6 -0 27- 9 6 .4 g in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n 1 0 1 Pro duct

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 0 7/10 /20 19

FLEXIBLE PAIN RELIEF pain relief lotion lotion Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:730 9 6 -0 26 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED MENTHOL, UNSPECIFIED 4534 mg FORM - UNII:L7T10 EIP3A) FORM in 226 .7 g

Inactive Ingredients Ingredient Name Strength PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH) EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 ) ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ) CETYL ALCO HO L (UNII: 9 36 JST6 JCN) CO MFREY LEAF (UNII: DG4F8 T8 39 X) SAFFLO WER O IL (UNII: 6 5UEH26 2IS) WATER (UNII: 0 59 QF0 KO0 R) O LIVE O IL (UNII: 6 UYK2W1W1E) EDETATE SO DIUM (UNII: MP1J8 420 LU) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) CANNABIS SATIVA SEED O IL (UNII: 6 9 VJ1LPN1S) PHENO XYETHANO L (UNII: HIE49 2ZZ3T) TRO LAMINE (UNII: 9 O3K9 3S3TK) CARBO MER CO PO LYMER TYPE B (ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 8 0 9 Y72KV36 ) DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCO SAMINE SULFATE PO TASSIUM CHLO RIDE (UNII: 15VQ11I6 6 N) GLYCERIN (UNII: PDC6 A3C0 OX) HEMP (UNII: TD1MUT0 1Q7) 50 0 mg in 226 .7 g SALIX ALBA BARK (UNII: 20 5MXS71H7)

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:730 9 6 -0 26 - 226 .7 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n 1 0 6 /26 /20 19 0 1 Pro duct

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 0 6 /26 /20 19 Labeler - Harmony Product LLC (117041828)

Registrant - Steuart Custom Manufacturing (116952121)

Establishment Name Addre ss ID/FEI Busine ss Ope rations Steuart Custo m Manufacturing 116 9 52121 manufacture(730 9 6 -0 26 , 730 9 6 -0 27, 730 9 6 -0 28 , 730 9 6 -0 29 , 730 9 6 -0 30 )

Revised: 10/2019 Harmony Product LLC