Label: CARE ONE COOL HEAT PAIN RELIEVING- menthol, methyl salicylate cream

  • 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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  • ACTIVE INGREDIENT

    Active ingredients                                                                                     Purpose

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

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

  • PURPOSE

    Uses

    temporarily relieves minor pain associated with

    • Arthritis
    • Simple backache
    • Muscle strains
    • Sprains
    • Bruises
    • Cramps
  • WARNINGS

    Warning

    For external use only

    Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

  • WHEN USING

    When using this product

    • Use only as directed
    • Do not bandage tightly or sue with a heating pad
    • Avoid contact with eyes or mucous membranes
    • Do not apply to wounds, damaged, broken or irritated skin
  • 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
  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • 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
    Children 12 years or younger: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

    Carbomer, Cetyl Esters, Emulsifying Wax, Oleth-3 phosphate, Stearic Acid, Triethanolamine, Water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY: AMERICAN SALES COMPANY

    4201 WALDEN AVENUE, LANCASTER, NY 14086

    www.care1.info

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    CARE ONE COOL HEAT PAIN RELIEVING 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-863
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-863-351 in 1 CARTON
    135 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2012
    Labeler - AMERICAN SALES COMPANY (809183973)
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