Label: SOOTHING PAIN RELIEF ROLL ON- menthol, unspecified form gel

  • 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 9, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Menthol 2%

  • Purpose

    Topical analgesic

  • Indications

    for the temporary relief of minor aches and pains of muscles and joints associated with

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

    • For external use only.

    • Avoid contact with the eyes.

    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a Physician.

    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Adults and children 2 years of age and older:
      apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age, consult a Physician.
  • Inactive ingredients

    Water, Butylene Glycol, Aloe Barbadensis Leaf Juice, Eucalyptus Globulus Leaf Oil, Methyl Salicylate, Camphor, Mentha Piperita (Peppermint) Oil, Silica, Potassium Citrate, Magnesium Carbonate, Oleic Acid, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.

  • PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label

    Soothing
    Pain Relief

    Roll-On

    2 Fl Oz (59.1 ml)

    Rejuvenetics™

    PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    SOOTHING PAIN RELIEF   ROLL ON
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64483-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Camphor (synthetic) (UNII: 5TJD82A1ET) 0.52 mg  in 100 mL
    Water (UNII: 059QF0KO0R)  
    Eucalyptus oil (UNII: 2R04ONI662)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64483-008-0259.1 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/04/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/04/2014
    Labeler - Clientele, Inc. (085021806)
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