Label: CVS EXTRA STRENGTH COLD AND HOT PAIN RELIEVING- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-469-09 - Packager: CVS
- 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 October 13, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- Adults and children over 12 years:
- apply generously to affected area
- massage into painful area until thoroughly into skin
- repeat as necessary, but no more than 4 times daily
- close cap tightly after use
- keep carton as it contains important information
- Children 12 years or younger: Ask a doctor
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS EXTRA STRENGTH COLD AND HOT PAIN RELIEVING
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-469 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 30 g in 100 g Inactive Ingredients Ingredient Name Strength DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-469-09 1 in 1 CARTON 1 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/13/2014 Labeler - CVS (062312574)