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 August 19, 2021

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  • ACTIVE INGREDIENT

    Menthol

    Methyl Salicylate

  • PURPOSE

    Topical analgesic

  • 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.

  • INDICATIONS & USAGE

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

  • 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


  • 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

  • INACTIVE INGREDIENT

    Citric Acid, Glyceryl Monostearate, Lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Polysorbate 80, Stearic Acid, Trolamine

  • PRINCIPAL DISPLAY PANEL

    MUS3 Carton

  • INGREDIENTS AND APPEARANCE
    CAREALL MUSCLE RUB  ULTRA STRENGTH
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol100 mg  in 1 g
    Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    LANOLIN (UNII: 7EV65EAW6H)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Colorwhite (White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-007-0385 g in 1 TUBE; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2012
    Labeler - New World Imports, Inc (075372276)
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