KAPSIN- camphor (synthetic), capsaicin ointment Apipharmausa, 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. ------Kapsin

Drug Facts

Active ingredients Camphor 3.16% Capsaicin 0.03%

Purpose External Analgesic

Uses for temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Warnings For external use only.

When using this product avoid contact with eyes do not apply to wounds or damaged skin do not bandage tightly

Stop use and consult a doctor if: condition worsens or if symptoms persist for more than 7 days if conditions clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: consult a doctor

Other information store at 77°F (25°C)

Inactive ingredients alcohol, chili pepper (capsicum frutescens) fruit extract, lanolin wax, petrolatum, propolis wax, water. Package Labeling: KAPSIN camphor (synthetic), capsaicin ointment

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:730 6 1-0 0 3

Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHO R (SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) - CAMPHOR 31.6 mg UNII:5TJD8 2A1ET) (SYNTHETIC) in 1 g CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM) CAPSAICIN 0 .3 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCO HO L (UNII: 3K9 9 58 V9 0 M) CAPSICUM (UNII: 0 0 UK76 46 FG) PETRO LATUM (UNII: 4T6 H12BN9 U) PRO PO LIS WAX (UNII: 6 Y8 XYV2NOF) WATER (UNII: 0 59 QF0 KO0 R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:730 6 1-0 0 3-6 0 1 in 1 BOX 0 9 /0 4/20 20 1 6 0 g in 1 TUBE; Type 0 : No t a 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 9 /0 4/20 20

Labeler - Apipharmausa, LLC (117030000)

Revised: 9/2020 Apipharmausa, LLC