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DEEP REMEDY (SOMBRA COSMETICS INC.)

Available Formats

Dosage Form Package Information Links
GEL 14.2 g in 1 JAR (61577-3610-1) Label Information
GEL 58.7 g in 1 JAR (61577-3610-2) Label Information
GEL 226.8 g in 1 JAR (61577-3610-8) Label Information
GEL 5 g in 1 POUCH (61577-3610-5) Label Information
GEL 113.4 g in 1 JAR (61577-3610-4) Label Information

Complete DEEP REMEDY Information

  • 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, 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

  • Questions or Comments

    1-800-225-3963

  • PRINCIPAL DISPLAY PANEL

    label


    deep30001.jpg
  • INGREDIENTS AND APPEARANCE
    DEEP REMEDY  
    menthol camphor gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-3610
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .03 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) .03 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 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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