Label: DEEP REMEDY - menthol and camphor (synthetic) gel

  • NDC Code(s): 61577-3610-1, 61577-3610-2, 61577-3610-4, 61577-3610-5, view more
    61577-3610-8
  • Packager: SOMBRA COSMETICS INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Menthol USP 3%

    Camphor USP 3%

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  • Purpose

    Purpose

    External Analgesic
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  • Keep out of reach of children

    Keep out of reach of children

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  • Uses

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

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  • 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.

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  • 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.

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  • Inactive Ingredients

    aloe vera extract, capsaicin, carbomer, decyl polyglucose, deinoized 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

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  • Questions or Comments

    1-800-225-3963

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  • PRINCIPAL DISPLAY PANEL

    label


    deep30001.jpg
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  • INGREDIENTS AND APPEARANCE
    DEEP REMEDY  
    menthol camphor gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61577-3610
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL .03 g  in 1 g
    CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) .03 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    CAPSICUM  
    CARBOMER HOMOPOLYMER TYPE C  
    DECYL GLUCOSIDE  
    WATER  
    GRAPEFRUIT SEED OIL  
    GREEN TEA LEAF  
    ORANGE PEEL  
    FILIPENDULA ULMARIA FLOWER  
    ROSA CENTIFOLIA FLOWER OIL  
    SODIUM HYDROXYMETHYLGLYCINATE  
    GLYCERIN  
    WITCH HAZEL  
    YUCCA SCHIDIGERA ROOT  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61577-3610-5 5 g in 1 POUCH
    2 NDC:61577-3610-2 58.7 g in 1 JAR
    3 NDC:61577-3610-4 113.4 g in 1 JAR
    4 NDC:61577-3610-8 226.8 g in 1 JAR
    5 NDC:61577-3610-1 14.2 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/01/2013
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Registrant - SOMBRA COSMETICS INC. (097464309)
    Establishment
    Name Address ID/FEI Business Operations
    SOMBRA COSMETICS INC. 097464309 manufacture(61577-3610), label(61577-3610)
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