Label: FROZEN ICE FAST PAIN RELIEF (menthol camphor- natural gel

  • 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 November 24, 2016

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Menthol 3.5%Topical Analgesic
    Camphor 0.2%Topical Analgesic
  • INACTIVE INGREDIENT

    Carbomer, Propylene Glycol, Methylparaben, Isopropyl Alcohol, Triethanolamine, FD&C Blue #1, Purified Water.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN

  • WARNINGS

    For the external use only. Use only as directed.

    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occurs again within a few days, discontinue use of this product and consults a doctor.
    • Avoid contact with eyes.
    • Do not use with other topical products.
    • Do not use with heating device.
    • Do not apply to open wounds or damaged skin.

    In case of accidental ingestion, seek professional help and contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older.
    Apply to painful muscles and joints.
    Gently massage thoroughly into affected area.
    Repeat as necessary but no more than 4 times daily

  • PURPOSE

    Topical Analgesic

  • Other Information:

    Store in cool, dry location at room temperature 59°- 86°F (15° - 30°C) with cao closed tightly. Keep away from excessive heat or open flame.

    Manufactured by:

    GABAL Laboratories, Inc.

    Miami, FL 33186 – (305)382-3288

    www.gadallaboratories.com

    MADE IN USA

  • FROZEN ICE FAST PAIN RELIEF

    Label Image
  • INGREDIENTS AND APPEARANCE
    FROZEN ICE FAST PAIN RELIEF 
    menthol camphor (natural) gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-363
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-363-0389 mL in 1 APPLICATOR; Type 0: Not a Combination Product11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2016
    Labeler - GADAL Laboratories, Inc (841305639)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(53113-363)
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