MUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]

MUSCLE RUB (MENTHOL) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]
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NDC 52000-020-37, 52000-020-38
Set ID 4481b268-8e92-4dab-a376-98db8b360a7c
Category HUMAN OTC DRUG LABEL
Packager Universal Distribution Center LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 2.5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    • Provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.
  • WARNINGS

    Warnings

    For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

    • Avoid contact with eyes or mucous membranes.
    • Discontinue use if excessive irritation of the skin develops.
    • Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad.
    • If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.
    • For arthritis like conditions in children under 12, do not use. Consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily and gently massage until gel disappears.
    • Children under 12 years of age: do not use, consult a doctor
  • SPL UNCLASSIFIED SECTION

    Other Information

    • Store at controlled room temperature 15°C to 30°C (59°F to 86°F)
    • Lot No. & Exp. Date: see crimp of tube.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide, Water

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    MUSCLE RUB GEL

    NET WT 1.25 OZ (35 g)

    image of package label

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    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:52000-020-371 in 1 BOX12/13/2020
    1NDC:52000-020-3835 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 finalpart34804/15/2015
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-020)

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