Label: CVS EXTRA STRENGTH COLD AND HOT PAIN RELIEVING- menthol cream

  • 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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  • ACTIVE INGREDIENT

    Active ingredients                                                                         Purpose

    Menthol 10%..................................................................Topical Analgesic

    Methyl Salicylate 30%....................................................Topical Analgesic

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  • PURPOSE

    Uses temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps
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  • WARNINGS

    Warnings

    • For external use only
    • Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
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  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
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  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • irritation develops
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

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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
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  • INACTIVE INGREDIENT

    Inactive ingredients DEA-cetyl phosphate, isopropyl myristate, lanolin, methylparaben, polysorbate 60, propylparaben, stearic acid, stearyl alcohol, trolamine, water

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  • DOSAGE & ADMINISTRATION

    Distributed By:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    CVS EXTRA STRENGTH COLD AND HOT PAIN RELIEVING 
    menthol cream
    Product 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)
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