Label: INFLAMMATION OTC DEEP PAIN CARE COLD- camphor, menthol 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 16, 2011

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  • Active Ingredient

    Camphor (3.0%)

    Menthol (2.6%)

  • Purpose

    Topical Analgesic

    Counterirritant

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • sprains
  • Warnings

    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

    In case of accidental ingestion seek professional assistance or contact a poison control 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, dimethyl sulfone, glycerin, glycine soja (soybean) oil, eucalyptus globulus oil, piper nigrum (pepper) seed extract, centipedia cunninghamii extract, arctium majus root (burdock) extract, mentha piperita (peppermint) leaf extract, artemisia absinthium, uncaria tomentosa extract, zingiber officinale (ginger) root oil, arnica montana flower extract, zingiber officinale (ginger) root extract, d-ribose, sodium polycrylate, c18-21 alkane, trideceth-6, tocopherol, phenoxyethanol, iodopropynyl butylcarbamate

  • Questions or Comments

    Store between 35 F and 80 F

    call 1-912-236-9430 weekdays

  • Principal Display Panel

    Inflammation OTC

    Deep Pain Care Cold

    New wt 1.1 oz. (31 mL)

    Manufactured by SkinDeep for SkinFit Distributors

    Savannah, GA 31405

    Tel: 912-236-9430

    www.mwlabs.com

    Inflammation OTC Box

  • INGREDIENTS AND APPEARANCE
    INFLAMMATION OTC  DEEP PAIN CARE COLD
    camphor, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941) Camphor (Natural)18 g  in 600 g
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol16 g  in 600 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Black Pepper Oil (UNII: U17J84S19Z)  
    Soybean Oil (UNII: 241ATL177A)  
    Arctium Lappa Root (UNII: 597E9BI3Z3)  
    Peppermint (UNII: V95R5KMY2B)  
    Wormwood (UNII: F84709P2XV)  
    Cat's Claw (UNII: 9060PRM18Q)  
    Ginger Oil (UNII: SAS9Z1SVUK)  
    Arnica Montana (UNII: O80TY208ZW)  
    Ginger (UNII: C5529G5JPQ)  
    Trideceth-6 (UNII: 3T5PCR2H0C)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45156-5610-21 in 1 BOX
    1NDC:45156-5610-131 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34808/16/2011
    Labeler - Skin Deep (833276566)
    Establishment
    NameAddressID/FEIBusiness Operations
    Skin Deep833276566manufacture
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