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Name:Bengay Cold Therapy With Pro-cool Technology
Manufacturer:Johnson & Johnson Consumer Products Company, Division Of Johnson & Johnson Consumer Companies, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BENGAY® Cold Therapy Menthol Pain Relieving Gel

BENGAY COLD THERAPY  WITH PRO-COOL TECHNOLOGY - menthol gel 
Johnson & Johnson Consumer Products company, Division of Johnson & Johnson Consumer Companies, Inc.

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.

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BENGAY® Cold Therapy
Menthol Pain Relieving Gel

Drug Facts

Active ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

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

  • simple backache
  • bruises
  • arthritis
  • sprains
  • strains

Warnings

For external use only.

Flammable: Keep away from fire or flame.

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. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • 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

Other Information

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

Inactive ingredients

alcohol, aminomethyl propanol, camphor, carbomer, disteareth-75 IPDI, ethylhexyl isononanoate, FD&C blue no. 1, glycerin, isopropyl alcohol, PEG-7 caprylic/capric glycerides, polysorbate 60, water

Questions?

call 1-800-223-0182

PRINCIPAL DISPLAY PANEL - 113g Tube Label

NEW

BENGAY®
menthol pain relieving gel

cold therapy
with PRO-COOL technology

cooling

FAST ACTING PAIN RELIEF

Same technology used
by chiropractors and
physical therapists

vanishing scent

NET WT 4 OZ (113g)

Principal Display Panel - 113g Tube Label

BENGAY COLD THERAPY   WITH PRO-COOL TECHNOLOGY
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58232-4029
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Alcohol  
Aminomethylpropanol  
Camphor (Synthetic)  
Ethylhexyl Isononanoate  
FD&C Blue No. 1  
Glycerin  
Isopropyl Alcohol  
Polysorbate 60  
Water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58232-4029-2 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 113 g in 1 TUBE This package is contained within the CARTON (58232-4029-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 10/25/2010

Labeler - Johnson & Johnson Consumer Products company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 09/2010 Johnson & Johnson Consumer Products company, Division of Johnson & Johnson Consumer Companies, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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