Label: INFLAMMATION OTC BRUISE RELIEF- camphor lotion

  • 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 August 8, 2011

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  • Active Ingredient

    Camphor (3.16%)

  • Purpose

    Counterirritant

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with bruises

  • Warning

    For external use only

    Avoid contact with the eyes

    If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

    Do not apply to wounds or damaged skin

    Do not bandage tightly

  • Keep out of reach of children

    Keep out of reach of children

    In case of accidental ingestion seek professional assistance or contact a poison control center immediately

  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age: Consult a physician

  • Inactive Ingredients

    water, glycine soja (soybean) oil, glycerin, panthenol, alcohol, ascorbic acid, citrus medica limonum (lemon) peel extract, niacinamide, petasites japonicus (butterbur) root extract, glycereth-7 trimethyl ether, sodium polycrylate, c18-21 alkane, lactobacillus/bean seed extract/sodium glutamate ferment filtrate, uncaria tomentosa extract, calendula officinale (ginger) root extract, tocopherol, urea, yeast amino acid, arctium majus root (burdock) extract, trideceth-6, ruscus aculeatus root extract, inositol, taurine, trehalose, centipeda cunninghamii extract, saccharomyces/calcium ferment, saccharomyces/copper ferment, saccharomyces/manganese ferment, saccaromyces/zinc ferment, vitamin k, iodopropynyl butylcarbamate, phenoxyethanol

  • Questions and Comments

    Store between 35 F and 80 F

    call 1-912-236-9430 weekdays

  • Principal Display Panel

    Inflammation OTC

    Bruise Relief

    Net wt 1 oz. (28.5 mL)

    Manufacture by SkinDeep for SkinFit Distributors

    Savannah, Georgia 31405

    Tel: 912-236-9430

    www.mwlabs.com

    Inflammation OTC Box

  • INGREDIENTS AND APPEARANCE
    INFLAMMATION OTC  BRUISE RELIEF
    camphor lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941) Camphor (Natural)32 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Alcohol (UNII: 3K9958V90M)  
    Dexpanthenol (UNII: 1O6C93RI7Z)  
    Soybean Oil (UNII: 241ATL177A)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Lemon Oil (UNII: I9GRO824LL)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Niacinamide (UNII: 25X51I8RD4)  
    Cat's Claw (UNII: 9060PRM18Q)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Wormwood (UNII: F84709P2XV)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Ginger (UNII: C5529G5JPQ)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Urea (UNII: 8W8T17847W)  
    Saccharomyces Cerevisiae (UNII: 978D8U419H)  
    Arctium Lappa Root (UNII: 597E9BI3Z3)  
    Trideceth-6 (UNII: 3T5PCR2H0C)  
    Ruscus Aculeatus Root (UNII: ZW12V95I1Q)  
    Betaine (UNII: 3SCV180C9W)  
    Inositol (UNII: 4L6452S749)  
    Taurine (UNII: 1EQV5MLY3D)  
    Trehalose (UNII: B8WCK70T7I)  
    Phytonadione (UNII: A034SE7857)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45156-5502-21 in 1 BOX
    1NDC:45156-5502-129 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34808/08/2011
    Labeler - Skin Deep (833276566)
    Establishment
    NameAddressID/FEIBusiness Operations
    Skin Deep833276566manufacture
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