Label: ANALGESIC- menthol gel

  • NDC Code(s): 61010-8202-0
  • Packager: Safetec of America, 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 October 1, 2018

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  • Active Ingredients

    USP Menthol 7%

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief of minor aches and pains of muscles and joints.

  • Warnings

    For external use only.

    Flammable.

    Keep away from flame.

    Keep out of reach of children.

    If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

  • Directions

    For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil, Xanthan Gum.

  • Principal Display Panel - Pain Relief Roll-On Bottle Label

    NDC 61010-XXXX-X

    Safetec

    PAIN
    RELIEF
    ROLL-ON

    MEDICATED FAST-ACTING

    For temporary relief of
    minor aches and pains

    3 fl. oz. (88 ml)

    Reorder no. 58001

    Principal Display Panel - Pain Relief Roll-On Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol70 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    isopropyl alcohol (UNII: ND2M416302)  
    glycerin (UNII: PDC6A3C0OX)  
    eucalyptus oil (UNII: 2R04ONI662)  
    methyl salicylate (UNII: LAV5U5022Y)  
    peppermint oil (UNII: AV092KU4JH)  
    coconut oil (UNII: Q9L0O73W7L)  
    xanthan gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-8202-00.088 L in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2018
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE(61010-8202)
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