Label: MUSCLE RUB ULTRA STRENGTH PAIN RELIEVING- menthol 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 July 10, 2013

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

  • Active Ingredient

    Drug Facts

    Menthol 2.5%

  • 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.

  • Uses

    Temporarily relieves the minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only.

    Do not use on

    • 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 mucus membranes
    • do not bandage tightly


    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • excessive skin irritation occurs
    • symptoms clear up and occur again within a few days
  • 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 between 59° and 86° F  (15° and 30° C)
    • close cap tightly after use
    • do not use if seal on tube is punctured or missing
  • Inactive ingredients

    camphor, carbomer, DMDM hydantoin,PEG-40 hydrogenated castor oil, isopropyl alcohol, stearic acid, glyceryl monostearate, purified water, sodium hydroxide.

  • Product Label

    DRUGSTORE-Rx

    SMART WELLNESS

    Ultra Strength

    Muscle Rub

    Pain Relieving Cream Analgesic


    Relieves minor

    • Arthritis
    • Backache
    • Muscle pain
    • Joint pain


    Fast penetrating

    Long lasting

    NET WT. 1.5 OZ. (42 g)

    DRUGSTORE-Rx

    SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item. That's smart wellness!

    Distributed by: PERSONAL CARE PRODUCTS, LLC
    Troy, Michigan 48084 U.S.A.

    Code No. MH/DRUGS/KD-313               Made in India


    PC MuscleRub1 Label

    PC MuscleRub4 Label








  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB  ULTRA STRENGTH PAIN RELIEVING
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2433
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.05 g  in 42 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-2433-142 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/10/2013
    Labeler - Personal Care Products, Inc. (966155082)
    Registrant - Personal Care Products, Inc. (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2433)