Label: ONEBACK- menthol 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 April 30, 2015

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    NATURAL MENTHOL 3.9%

  • PURPOSE

    PURPOSE

    COOLING PAIN RELIEF

  • INDICATIONS & USAGE

    USES

    TEMPORARY RELIEF OF

    • ARTHRITIS
    • BACKACHE
    • STRAINS
    • SPRAINS
  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES, AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER.

    DO NOT USE WITH HEATING PAD OR DEVICE, OR UNDER BANDAGE.

    DO NOT USE IF PREGNANT OR BREAST FEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE.

    DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY
    • RUB IN THOROUGHLY UNTIL IT IS ABSORBED.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    WATER, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT, HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT, BOSWEILA SERRATA EXTRACT, CAMPHOR FOR SCENT

  • PRINCIPAL DISPLAY PANEL

    Label Cool Pain Relieving Gel 3oz. (2.13.2015)

  • INGREDIENTS AND APPEARANCE
    ONEBACK 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69643-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    UNCARIA TOMENTOSA LEAF (UNII: 487U8M3D2P)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69643-101-1188.8 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 finalpart34803/03/2015
    Labeler - WORLD WIDE MEDICAL SERVICES, INC. (101816366)
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