Label: CARE ONE COOL HEAT PAIN RELIEVING- menthol, methyl salicylate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-863-35 - Packager: AMERICAN SALES COMPANY
- 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 March 1, 2012
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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 absorbed into skin
- repeat as necessary but no more than 4 times daily
- close cap tightly after use
- keep carton as it contains important information
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CARE ONE COOL HEAT PAIN RELIEVING
menthol, methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-863 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) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 30 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ESTERS WAX (UNII: D072FFP9GU) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-863-35 1 in 1 CARTON 1 35 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2012 Labeler - AMERICAN SALES COMPANY (809183973)