GADADERM FROZEN ICE ADVANCE PAIN RELIEF (SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)) GEL [GADAL LABORATORIES, INC]

GADADERM FROZEN ICE ADVANCE PAIN RELIEF (SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)) GEL [GADAL LABORATORIES, INC]
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NDC 53113-362-09
Set ID 7bf21905-975a-472d-a2d6-a9c1408e7f95
Category HUMAN OTC DRUG LABEL
Packager GADAL Laboratories, Inc
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENTS

    Active IngredientsPurpose
    Methyl Salicylate 10%Topical Analgesic
    Menthol 10%Topical Analgesic
    Camphor 3.1%Topical Analgesic
  • INACTIVE INGREDIENT

    Carbopol, Cetearyl Alcohol, Disodium EDTA, FD&C Blue #1, Glycerin, Hydroxypropyl Methylcellulose, Menthylparaben, Propylene Glycol, Propylparaben, Polysorbate 20, Purified Water, Stearic Acid, Sodium Hydroxide.

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

  • WARNINGS

    For the external use only. When using this product use as directed.

    • Do not bandage tightly or use with heating pad. Avoid contact with eyes and mucous membranes.
    • Do not apply to wounds or damaged, broken, or irritated skin.
    • If severe burning sensation occurs, discontinue use immediately.
    • Do not expose the area treated with product to heat or direct sunlight.
    • Stop use and ask a doctor if conditions worsen, redness is present, irritation develops.

    If swallowed, get medical help or contact a Poison Control Center right away. IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older; apply generously to affected area massage into painful area until thoroughly absorbed into skin. Repeat as necessary but not more than 3 to 4 times daily.

  • PURPOSE

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

  • GADADERM Frozen Ice Advance Pain Relief

    Label Image
  • INGREDIENTS AND APPEARANCE
    GADADERM FROZEN ICE ADVANCE PAIN RELIEF 
    salicylic acid menthol camphor (natural) gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-362
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10   in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10   in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.1   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-362-0999 g in 1 TUBE; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2016
    Labeler - GADAL Laboratories, Inc (841305639)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(53113-362)

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