Label: ASSURED MUSCLE RUB- menthol gel

  • NDC Code(s): 33992-1136-1
  • Packager: Greenbrier International, 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 December 28, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 2.5%

  • Purpose

    Topical Analgesic

  • Use

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

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

    For external use only.

    Avoid contact with the eyes or on mucous membranes.

    Do not use

    • on wounds or damaged skin

    Stop use if

    • excessive irritation develops

    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

    When using this product

    • do not bandage or wrap tightly

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • Adults and children 2 years of age and older: apply to affected area up to 3 to 4 times daily.
    • Children under 2 years of age: consult a doctor
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    Camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, purified water, sodium hydroxide

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    GREENBRIER INTERNATIONAL, INC.
    500 VOLVO PARKWAY
    CHESAPEAKE, VA 23320

  • PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton

    ASSURED™

    EXTRA STRENGTH PAIN RELIEVING GEL

    Muscle Rub

    Menthol 2.5%

    Fast relief from:

    • Arthritis pain
    • Backache
    • Muscle pain
    • Joint pain

    NET WT 1.5 OZ (42.5 g)

    PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ASSURED  MUSCLE RUB
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1136
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1136-142.5 g in 1 TUBE; Type 0: Not a Combination Product05/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/15/2012
    Labeler - Greenbrier International, Inc. (610322518)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(33992-1136)
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