BENGAY ZERO DEGREES MENTHOL PAIN RELIEVING- menthol gel

Bengay Zero Degrees Menthol Pain Relieving by

Drug Labeling and Warnings

Bengay Zero Degrees Menthol Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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
• arthritis
• strains
• bruises
• sprains

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
  • for first use: remove and discard foil on applicator head
  • after use, wipe off applicator head, turn dial back slightly, and replace protective cap
  • clean outside with damp cloth or paper towel. do not rinse under or immerse in water.
  • Return product to storage
• children under 12 years of age: ask a doctor

Other information

• product may be stored in freezer out of reach of children. Place product in freezer a minimum of 2 hours before use, or
• product may be stored at 20° to 25°C (68° to 77°F) and applied at room temperature, but will not feel as refreshing as when stored in freezer
• protect from excessive heat 40°C (104°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, propylene glycol, water

Questions?

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

PRINCIPAL DISPLAY PANEL - 85 g Container Bag Label

[May be stored in the FREEZER in this reusable bag]

no mess applicator

BENGAY®
MENTHOL PAIN RELIEVING GEL

Zero degrees®
cooling pain relief

lasts for hours

soothing icy
sensation

light vanishing scent

NET WT 3 OZ (85 g)

INGREDIENTS AND APPEARANCE

BENGAY ZERO DEGREES MENTHOL PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-4036
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	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Aminomethylpropanol (UNII: LU49E6626Q)
Camphor (Synthetic) (UNII: 5TJD82A1ET)
Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Alcohol (UNII: ND2M416302)
PEG-7 CAPRYLIC/CAPRIC GLYCERIDES (UNII: AO33GZ05NB)
Polysorbate 60 (UNII: CAL22UVI4M)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-4036-1	1 in 1 POUCH	09/15/2011
1		85 g in 1 CANISTER; 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	09/15/2011

Labeler - Johnson & Johnson Consumer Inc. (002347102)