SPORTSCREME- trolamine salicylate cream Chattem, Inc. 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. ------Sportscreme

SPORTSCREME® Deep Penetrating Pain Relieving Rub

Active ingredient Trolamine Salicylate 10%

Purpose Topical

Uses temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle stains muscle sprains bruises cramps

Warnings Allergy alert: Do not use if you are allergic to salicylates (including ) unless directed by a doctor.

When using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with the eyes or mucous membranes do not apply to wounds or damaged skin

Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions adults and children over 10 years: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary no more than 4 times daily for temporary relief

Inactive ingredients cetyl alcohol, FD&C blue no. 1, FD&C yellow 5, fragrance, glycerin, methylparaben, mineral oil, potassium phosphate, propylparaben, stearic acid, , water (229-121)

Principal Display Panel Fast Pain Relief No Unpleasant Odor SPORTSCREME® Deep Penetrating Pain Relieving Rub Trolamine Salicylate (10%) Net wt 3 oz (85g) SPORTSCREME trolamine salicylate cream

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:4116 7-730 0 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRO LAMINE SALICYLATE (UNII: H8 O40 40 BHD) ( - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE 10 g in 10 0 g

Inactive Ingredients Ingredient Name Strength CETYL ALCO HO L (UNII: 9 36 JST6 JCN) FD&C BLUE NO . 1 (UNII: H3R47K3TBD) FD&C YELLO W NO . 5 (UNII: I753WB2F1M) GLYCERIN (UNII: PDC6 A3C0 OX) METHYLPARABEN (UNII: A2I8 C7HI9 T) MINERAL O IL (UNII: T5L8 T28 FGP) PO TASSIUM PHO SPHATE, UNSPECIFIED FO RM (UNII: B78 6 2WZ6 32) PRO PYLPARABEN (UNII: Z8 IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z6 5AP) TRO LAMINE (UNII: 9 O3K9 3S3TK) WATER (UNII: 0 59 QF0 KO0 R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:4116 7-730 0 -1 1 in 1 CARTON 0 1/0 1/19 9 9 12/0 4/20 14 1 35 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct 2 NDC:4116 7-730 0 -3 1 in 1 CARTON 0 1/0 1/19 9 9 2 8 5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct 3 NDC:4116 7-730 0 -4 1 in 1 CARTON 0 1/0 1/19 9 9 0 1/23/20 15 3 113 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 MONOGRAPH NOT FINAL part348 0 1/0 1/19 9 9

Labeler - Chattem, Inc. (003336013)

Establishment Name Addre ss ID/FEI Busine ss Ope rations CHATTEM, ANALYSIS(4116 7-730 0 ) , LABEL(4116 7-730 0 ) , MANUFACTURE(4116 7-730 0 ) , PACK(4116 7- 8 30 410 721 INC. 730 0 )

Revised: 1/1999 Chattem, Inc.