DR. WALTONS COOL AND HOT ANALGESIC (MENTHOL) GEL [DR. WALTONS, INCORPORATED]

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DR. WALTONS COOL AND HOT ANALGESIC (MENTHOL) GEL [DR. WALTONS, INCORPORATED]
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NDC 76271-003-08
Set ID 1a5ba55f-ae7e-4cf5-bbea-52523aa027c6
Category HUMAN OTC DRUG LABEL
Packager DR. WALTONS, INCORPORATED
Generic Name
Product Class
Product Number
Application Number PART346
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  • ACTIVE INGREDIENT

    MENTHOL: 1.0%

  • PURPOSE

    TOPICAL ANALGESIC

  • KEEP OUT OF REACH OF CHILDREN

    DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE

  • INDICATIONS & USAGE

    PROVIDES TEMPORARY RELIEF OF MINOR ACHES AND PAINS IN MUSCLES AND JOINTS ASSOCIATED WITH SIMPLE BACKACHE, STRAINS, ARTHRITIS AND SPORTS INJURIES.

  • WARNINGS

    FOR EXTERNAL USE ONLY. NOT FOR INTERNAL USES. AVOID CONTACT WITH EYES OR MUCOUS MEMBRANES. DO NOT APPLY TO OPEN WOUNDS OR DAMAGED SKIN. MAKE SURE SKIN IS CLEAN AND FREE FROM CREAMS, OINTMENTS, SPRAYS OR LINIMENT. DO NOT BANDAGE.

  • DOSAGE & ADMINISTRATION

    CLEAN SKIN OF ALL OTHER LOTIONS, CREAMS, OINTMENTS, LINIMENT OR SPRAYS. APPLY LIBERALLY TO AFFECTED AREA AND MASSAGE UNTIL ABSORBED INTO SKIN. DO NOT APPLY MORE THAN 3-4 TIMES DAILY. NO PROTECTIVE COVER NEEDED.

  • INACTIVE INGREDIENT

    WATER, ISOPROPYL ALCOHOL, NONOXYNOL-10, CAMPHOR, CARBOMER, SODIUM HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE AND METHYLISOTHIAZONLINONE, BLUE 1 (CI42090)

  • PRINCIPAL DISPLAY PANEL

    DR WALTONS COOL AND HOT LABEL

  • INGREDIENTS AND APPEARANCE
    DR. WALTONS COOL AND HOT ANALGESIC  
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76271-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.27 g  in 227 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76271-003-08227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/14/2011
    Labeler - DR. WALTONS, INCORPORATED (041377104)
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