Label: INFLAMMATION OTC DEEP PAIN CARE HOT- camphor, capsicum, 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 (0.46%)

    Capsicum Annuum Extract (0.025%)

    Menthol (1.7%)

  • Purpose

    Topical Analgesic

    Counterirritant

    Counterirritant

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • sprains
    For the temporary relief of pain

    Provides warming pain relief
  • Warnings

    For external use only

    Avoid contact with the eyes

    Do not apply to wounds or damaged skin

    Do not bandage tightly

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

  • 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, dimethyl sulfonate, glycerin, glycine soja (soybean) oil, eucalyptus globulus oil, piper nigrum (pepper) seed extract, sodium polycrylate, c18-21 alkane, niacinamide, artemisia absinthium, uncaria tomentosa extract, juniperus communis fruit oil, xanthan gum, zingiber officinate (ginger) root extract, arctium majus root (burdock) extract, arnica montana flower extract, trideceth-6, tocopherol, phenoxyethanol, iodopropynyl butylcarbamate

  • Questions and Comments

    store between 35 F and 80 F

    call 1-912-236-9430 weekdays

  • Principal Display Panel

    Inflammation OTC

    Deep Pain Care Hot

    New wt 1.1 oz. (31 mL)

    Manufactured by SkinDeep for SkinFit Distributors

    Savannah, GA 31405

    Tel: 1-912-236-9430

    www.mwlabs.com

    Deep_Pain_Hot Box

  • INGREDIENTS AND APPEARANCE
    INFLAMMATION OTC  DEEP PAIN CARE HOT
    camphor, capsicum, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5605
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941) Camphor (Natural)4 g  in 1000 g
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum38 g  in 1000 g
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol17 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Ginger (UNII: C5529G5JPQ)  
    Soybean Oil (UNII: 241ATL177A)  
    Arctium Lappa Root (UNII: 597E9BI3Z3)  
    Juniper Berry Oil (UNII: SZH16H44UY)  
    Cat's Claw (UNII: 9060PRM18Q)  
    Wormwood (UNII: F84709P2XV)  
    Black Pepper (UNII: KM66971LVF)  
    Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Niacinamide (UNII: 25X51I8RD4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Corymbia Citriodora Leaf Oil (UNII: M63U6N96EB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45156-5605-21 in 1 BOX
    1NDC:45156-5605-131 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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