Label: FAST RELIEF ARTROSAMIN- menthol, methyl salicylate 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 October 1, 2015

If you are a consumer or patient please visit this version.

  • DRUG FACTS

    Active Ingredient:                             Purpose:

    Menthol 2.5%...................................External Analgesic

    Methyl Salicylate 15%......................External Analgesic

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  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

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  • Warnings:

    • For external use only.
    • Do not use this product if safety seal is broken. Store in room temperature.
    • Do not use on wounds or damaged skin. Do not apply in large quantities, particularly on raw and irritated or blistered areas.
    • When using this product, avoid contact with eyes or mucus membranes. Use only as directed. Do not bandage tightly.
    • Stop and ask doctor if condition worsen, if symptoms persist within 7 days or clear up and occur again within a few days. Stop use if excessive skin irritation occurs.
    • If pregnant or breast feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning.

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  • DOSAGE & ADMINISTRATION

    Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or mucous membranes. If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.

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  • Directions

    Apply to the affected area. Gently massage into the skin for a few seconds. Adults and children over 12 years of age: apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age need to consult a physician.

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  • Inactive Ingredients:

    Acrymalide, Amino Acids, Comfrey Leaf, Cetyl Alcohol, Diazolidinyl Urea, Dimethicone, Glucosamine, Methyl Paraben, MSM (Methylsulfonylmethane), Mineral Oil, Panthenol, Propylene Glycol, Propylparaben, Sodium Pyrrolidone Carboxylate, Stearic Acid, Stearyl Alcohol, Trolamine, Water.

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  • Manufactured for:

    Interfarma Corp.

    Miami, FL 33186.

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  • FAST RELIEF ARTROSAMIN

    For Temporarily Relieves minor aches and pains soreness, and stiffness associated with simple backaches strains, arthritis and rheumatism.

    Net Wt 8 oz (226g)

    Made in USA

    image description

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  • INGREDIENTS AND APPEARANCE
    FAST RELIEF ARTROSAMIN 
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69706-0203
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ACRYLAMIDE (UNII: 20R035KLCI)  
    AMINO ACIDS, WHEAT (UNII: 0370GZL32F)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69706-0203-9 226 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/11/2013
    Labeler - Interfarma Corp (884091703)
    Registrant - Interfarma Corp (884091703)
    Establishment
    Name Address ID/FEI Business Operations
    Interfarma Corp 884091703 manufacture(69706-0203)
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