Label: MUSCLE RUB ULTRA- camphor,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 November 21, 2022

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  • Active Ingredients

    Camphor 4%

    Menthol 10%

    Methyl Salicylate 30%

  • Purpose

    Topical analgesic

    Topical analgesic

    Topical analgesic

  • Uses

    temporarily relieves the minor aches and pains of muscle and joints associated with:

    • simple bachache
    • arthritis
    • strains
    • bruises
    • 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 membranes
    • 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

    Keep out of reach of children to avoid accidental ingestion.

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    • 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
  • Other information

    • Store at 20° to 25°C (68°to 77° F)

  • Inactive Ingredients

    carbomer 940, cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, polysorbate 80, purified water, stearic acid, trolamine

  • Questions?

    call 1-800-883-0085, weekdays, 9AM -5PM PST

  • carton image

    image of carton

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB ULTRA 
    camphor,menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-773
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-773-041 in 1 BOX07/28/2011
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/25/2011
    Labeler - H E B (007924756)
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