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CARE ONE COOL HEAT PAIN RELIEVING (AMERICAN SALES COMPANY)

Available Formats

Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (41520-863-35) > 35 g in 1 TUBE Label Information

Complete CARE ONE COOL HEAT PAIN RELIEVING Information

  • 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 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)