Label: ANALGESIC BALM- menthol 10%, methyl salicylate 15% cream
- NDC Code(s): 57896-116-01
- Packager: Geri-Care Pharmaceuticals, Corp
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 29, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Active Ingredient
- PURPOSE
- INDICATIONS & USAGE
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Warnings
For external use only
Do not use:
- On wounds or damaged, broken or irritated skin
- On a child under 12 years of age with arthritis-like conditions
- With a heating pad
Ask a doctor before use if you have redness over the affected area.
When using this product
- Avoid contact with eyes or mucous membrane
- Do not bandage tightly
- Stop Use and ask a doctor
- Keep out of the reach of Children
- Directions
- Other Information
- Inactive Ingredients
- Distributed By
- Packaging
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INGREDIENTS AND APPEARANCE
ANALGESIC BALM
menthol 10%, methyl salicylate 15% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g in 100 g Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER 940 (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-116-01 1 in 1 BOX 08/05/2020 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/05/2020 Labeler - Geri-Care Pharmaceuticals, Corp (611196254) Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)