Label: DR. WALTONS COOL AND HOT ANALGESIC- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 14, 2011

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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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