PAIN RELIEVING (MENTHOL) GEL [CARDINAL HEALTH]

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PAIN RELIEVING (MENTHOL) GEL [CARDINAL HEALTH]
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NDC 37205-824-26
Set ID fcb2335a-497e-4c3e-bd75-780e9634f249
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredients

    Active Ingredients                   
    Menthol 3.5%

    Purpose

    Cooling Pain Relief

  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with • arthritis • backache • strains • sprains

  • Warnings:

    For external use only

    Ask a doctor before use if you have:

    sensitive skin, are pregnant or breast feeding

    When Using This Product:

    • Avoid contact with eyes or mucous membranes

    • Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops

    • Do not bandage or use with heating pad or device. ointments, creams, sprays. liniments

    • Wash hands after with cool water

    Stop Use And Ask A Doctor If:

    Condition worsens. symptoms persist more than 7 days, or clear up and recur

    Keep out of reach of children:

    If ingested, get medical help. Contact Poison Control Center immediately.

  • Directions:

    • Adults / Children 2 years and older: Massage onto affected area up to 4 times daily.  • Children under 2 years of age: Consult physician

  • Other Information:

    Store in cool dry place, lid closed tightly. keep away from excessive heat or open flame.

  • Inactive Ingredients:

    Water, isopropyl alcohol, herbal extract (IIex paraguariensis), menthol, carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FDandC blue #1

  • Package Labeling:

    PainRelievingGelA

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-824
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-824-261 in 1 CARTON01/18/2012
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/18/2012
    Labeler - Cardinal Health (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    Span Packaging Services LLC117101131manufacture(37205-824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Span Packaging Services LLC557434805manufacture(37205-824)
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