Label: WAKAYA RURU TOPICAL ANALGESIC- external analgesic cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated October 18, 2022

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  • Active Ingredient

    Menthol 1.25%..................... Topical Analgesic

  • PURPOSE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children.

    If pregnant or breast-feeding, ask a health professional before use.

    If swallowed get medical help or contact poisoncontrol center right away.

  • Inactive Ingredients

    Water

    Cetylated Fatty Acids (Myristoleate, Myristate, Laurate, Palmitate, and Oleate)

    Stearic Acid

    Glyceryl Stearate

    Glycerin

    Benzyl Alcohol

    Mentha Piperita (Peppermint Oil)

    Lecithin

    Phenoxyethanol

    Sodium Hydroxide

    Carbomer

    Tocopheryl Acetate

  • Warnings

    For external use only.

    Avoid contact with eyes.

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

    Do not bandage tightly

  • DIRECTIONS

    Adults ands children 2 years of age and older: Apply to affected area not more than 3 to 4 times per day. Children under 2 years of age: Consult a physician

  • Other Information

    Store in a cool, dry place.

  • INDICATIONS & USAGE

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

  • label

    label

  • INGREDIENTS AND APPEARANCE
    WAKAYA RURU TOPICAL ANALGESIC 
    external analgesic cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65112-265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 75 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65112-265-0171 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/13/2021
    Labeler - I Shay Cosmetics Inc (151582384)
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