Label: PAIN RELIEVING ROLL-ON- menthol, unspecified form gel

  • NDC Code(s): 61010-1550-1
  • 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 7, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Methyl Salicylate, Purified Water, Tea Tree Oil, Xanthan Gum.

  • Principal Display Panel - 3 oz. Bottle Label

    Safetec

    PAIN RELIEVING

    ROLL-ON

    FAST-ACTING MUSCLE RELIEF

    with Tea Tree & Eucalyptus Oils

    Reorder No. 58003

    3 fl. oz. (88ml) • Topical Analgesic

    Principal Display Panel - 3 oz. Bottle Label
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING ROLL-ON 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-1550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    menthol, unspecified form (UNII: L7T10EIP3A) (menthol, unspecified form - UNII:L7T10EIP3A) menthol, unspecified form7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    eucalyptus oil (UNII: 2R04ONI662)  
    glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    methyl salicylate (UNII: LAV5U5022Y)  
    water (UNII: 059QF0KO0R)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-1550-188 mL in 1 BOTTLE; Type 0: Not a Combination Product10/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/07/2019
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(61010-1550)