Label: EQUATE COOL AND HEAT- menthol, methyl salicylate cream
- NDC Code(s): 49035-470-01
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 February 7, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- If pregnant or breast-feeding,
- Keep Out of Reach of Children
- Directions
- Inactive Ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
EQUATE COOL AND HEAT
menthol, methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-470 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 100 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 300 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOCETETH-20 (UNII: O020065R7Z) POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-470-01 1 in 1 CARTON 09/17/2018 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 not final part348 09/17/2018 Labeler - Wal-Mart Stores Inc (051957769)