FROZEN ICE FAST PAIN RELIEF (MENTHOL CAMPHOR (NATURAL)) GEL [GADAL LABORATORIES, INC]

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FROZEN ICE FAST PAIN RELIEF (MENTHOL CAMPHOR (NATURAL)) GEL [GADAL LABORATORIES, INC]
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NDC 53113-363-03
Set ID 636cb454-eef9-4509-96cd-7deeb2abd0ac
Category HUMAN OTC DRUG LABEL
Packager GADAL Laboratories, Inc
Generic Name
Product Class
Product Number
Application Number PART341
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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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