Label: ANALGESIC BALM- menthol 10%, methyl salicylate 15% cream
- NDC Code(s): 57896-116-03
- Packager: Geri-Care Pharmaceuticals, Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 7, 2024
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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 (open) 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 membranes
- 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:57896-116-03 1 in 1 BOX 08/02/2021 1 85 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 Drug M017 07/30/2021 Labeler - Geri-Care Pharmaceuticals, Corp (611196254) Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)