Label: RETADOLOR PAIN RELIEF- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 21, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

  • Purpose

    Pain Relieving

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • sprains
    • bruises
  • Warnings

    For external use only.

    • do not apply to wounds or damaged skin
    • do not bandage tightly

    When using this product do not get into eyes

    • avoid contact with other mucous membranes

    Flammable

    Keep from heat and flame.

    Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    • if swallowed, get medical help or contact a Poison Control center right away

    • if pregnant or nursing, seek the advice of a health professional before using
  • Directions

    • Apply a thin layer to affected area not more than 4 times daily unless otherwise directed by your physician or pharmacist
    • Gently massage into the skin until fully absorbed
    • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
  • Inactive ingredients

    Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Acrylates Copolymer, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

  • PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

    RETADOLOR™
    The Anti-Pain™

    PENETRATING HEAT THERAPY CREAM

    Topical Analgesic for the Relief of
    ARTHRITIS, JOINT PAIN, MUSCLE
    ACHES AND CRAMPS

    #1
    Contains
    Capsaicin
    Recommended
    by Doctors

    ANTI-INFLAMMATORY
    OMEGA
    3, 6 & 9
    with
    IcePearls

    NET WT 3 OZ. (85g)

    Principal Display Panel - 85 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    RETADOLOR   PAIN RELIEF
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69279-144
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    ACAI OIL (UNII: Z0W6766A2W)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69279-144-1385 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34808/07/2015
    Labeler - LACAR SALES & MARKETING INC. (795293435)
    Establishment
    NameAddressID/FEIBusiness Operations
    Concept Laboratories, Inc.962282612MANUFACTURE(69279-144)
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