Label: TOTAL MUSCLE RELIEF- menthol, camphor gel

  • 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 August 2, 2019

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  • ACTIVE INGREDIENTS

    MENTHOL  3.9%

    cAMPHOR  0.4%

  • PURPOSE

    TOPICAL ANALGESIC

  • WARNINGS

    EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • USES

    TOPICAL RELIEF MUSCLE GEL

  • DIRECTIONS

    FOR ADULTS AND CHILDREN 2 YEARS AND OLDER. ROLL GEL ONTO AFFECTED AREA, REPEAT AS NEEDED. APPLICATIONS MAY BE REPEATED UP TO 4X DAILY OR AS DIRECTED BY A CARE PROVIDER. FOR CHILDREN UNDER 2 YEARS OF AGE, CONSULT A MEDICAL PROFESSIONAL.

  • INACTIVE INGREDIENTS

    PURIFIED WATER, ISOPROPYL ALCOHOL, EXTRACT OF ALOE VERA, HEMP GLOWER OIL, WITCH HAZEL AND SAGE, PROPYLENE GLYCOL, GLYCERIN, COCONUT OIL, SWEET ALMOND OIL, DIMETHICONE COPOLYOL SILICA, CARBOMER, TRIETHANOLAMINE, DMDM HYDANTOIN

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Topical Relief Muscle Gel

  • INGREDIENTS AND APPEARANCE
    TOTAL MUSCLE RELIEF 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73278-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.9 g  in 100 mL
    CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL0.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HEMP (UNII: TD1MUT01Q7)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    SAGE (UNII: 065C5D077J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73278-101-1390 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/16/2019
    Labeler - Nemadji Management LLC (100279564)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIVERSIFIED MANUFACTURING CORP185073996manufacture(73278-101)
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