Label: BENGAY GREASELESS PAIN RELIEVING- menthol, unspecified form and methyl salicylate cream

  • NDC Code(s): 69968-0022-2
  • Packager: Johnson & Johnson Consumer 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 April 25, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Menthol 10% Topical analgesic
    Methyl salicylate 15% Topical analgesic
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  • Uses

    temporarily relieves the minor aches and pains of muscles and joints associated with:

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

    For external use only.

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have redness over the affected area.

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs

    Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

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  • Directions

    • use only as directed
    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
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  • Other information

    • store at 20° to 25°C (68° to 77°F)
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  • Inactive ingredients

    cetyl alcohol, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, phenoxyethanol, potassium cetyl phosphate, potassium hydroxide, propylparaben, stearic acid, water, xanthan gum

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  • Questions?

    call 1-800-223-0182 or 215-273-8755 (collect)

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

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  • PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

    GREASELESS
    NON-GREASY CREAM

    BENGAY®
    PAIN RELEIVING CREAM

    NET WT 2 OZ (57 g)

    Principal Display Panel - 57 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    BENGAY GREASELESS PAIN RELIEVING 
    menthol, unspecified form and methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0022
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form 100 mg  in 1 g
    Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate 150 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Cetyl Alcohol (UNII: 936JST6JCN)  
    glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69968-0022-2 1 in 1 CARTON 12/15/2013
    1 57 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/15/2013
    Labeler - Johnson & Johnson Consumer Inc. (002347102)
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