Label: CAREALL MUSCLE RUB ULTRA STRENGTH- menthol, methyl salicylate cream

  • NDC Code(s): 51824-007-03
  • Packager: New World Imports, Inc
  • 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 June 9, 2017

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

  • ACTIVE INGREDIENT

    Menthol

    Methyl Salicylate

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  • PURPOSE

    Topical analgesic

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center Immediately.

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  • INDICATIONS & USAGE

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

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  • WARNINGS

    For external use only

    Do not use:

    On wounds or damaged skin

    With a heating pad

    On a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have

    redness over the affected area

    When using this product

    Avoid contact with eyes or mucous membrane

    Do not bandage tightly

    Stop use and ask a doctor if

    Condition worsens or symptoms persist for more than 7 days

    Symptoms clear up and occur again within a few days

    Excessive skin irritation occurs


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  • DOSAGE & ADMINISTRATION

    Use only as directed

    Adults and children 12 years of age and older; apply to affected area not more than 3 to 4 times daily

    Children under 12 years of age: ask a doctor

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  • INACTIVE INGREDIENT

    Citric Acid, Glyceryl Monostearate, lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine

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  • INGREDIENTS AND APPEARANCE
    CAREALL MUSCLE RUB  ULTRA STRENGTH
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-007
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 100 mg  in 1 g
    Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate 150 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Trolamine (UNII: 9O3K93S3TK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Color white (White) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51824-007-03 85 g in 1 TUBE; Type 0: Not a Combination Product 06/01/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/01/2012
    Labeler - New World Imports, Inc (075372276)
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