MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]

MUSCLE EASE (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]
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NDC 61577-2301-2, 61577-2301-4
Set ID 03fff4bf-04ed-49a6-b40f-4d98c2b42f69
Category HUMAN OTC DRUG LABEL
Packager SOMBRA COSMETICS INC.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Menthol USP 3%

    Camphor USP 3%

  • Purpose

    PURPOSE
    EXTERNAL ANALGESIC





  • Keep out of reach of children

    Keep out of reach of children

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with:  simple backaches, arthritis, strains, bruises, and sprains

  • Warnings

    For external use only.  Do not use on wounds or damaged skin.  When using this product:  avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

    Stop use and ask doctor if:  condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

  • Directions

    adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

  • Inactive Ingredients

    aloe vera extract, capsaicin, carbomer, decyl polyglucose, water, grapefruit seed extract, green tea extract, orange peel extract, queen of the prairie extract, rose water, sodium  hydroxymethylglycinate, vegetable glycerin, witch hazel, yucca extract

  • Questions or Comments

    1-800-225-3963

  • PRINCIPAL DISPLAY PANEL

    mm1
  • INGREDIENTS AND APPEARANCE
    MUSCLE EASE 
    menthol camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-2301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPSICUM (UNII: 00UK7646FG)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-2301-4113.4 g in 1 JAR; Type 0: Not a Combination Product02/21/2014
    2NDC:61577-2301-256.7 g in 1 TUBE; Type 0: Not a Combination Product02/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/16/2011
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS INC.097464309manufacture(61577-2301)

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