FAST RELIEF REUMACETIN (MENTHOL, METHYL SALICYLATE) CREAM [INTERFARMA CORP]

FAST RELIEF REUMACETIN (MENTHOL, METHYL SALICYLATE) CREAM [INTERFARMA CORP]
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NDC 69706-0204-9
Set ID 658689e9-d576-4bc2-bd03-db8dc9f2b0e3
Category HUMAN OTC DRUG LABEL
Packager Interfarma Corp
Generic Name
Product Class
Product Number
Application Number PART348
  • DRUG FACTS

    Active Ingredient:                             Purpose:

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

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

  • Uses

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

  • 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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning.

  • 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.

  • 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.

  • 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.

  • Manufactured for:

    Interfarma Corp.

    Miami, FL 33186.

  • FAST RELIEF REUMACETIN

    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

  • INGREDIENTS AND APPEARANCE
    FAST RELIEF REUMACETIN 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69706-0204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69706-0204-9226 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/11/2013
    Labeler - Interfarma Corp (884091703)
    Registrant - Interfarma Corp (884091703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Interfarma Corp884091703manufacture(69706-0204)

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