BENGAY COLD THERAPY- menthol, unspecified form gel

Bengay Cold Therapy by

Drug Labeling and Warnings

Bengay Cold Therapy 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
• children under 12 years of age: ask a doctor

Other information

Store at 20° to 25°C (68° to 77°F)

Inactive ingredients

water, ethanol, isopropanol, glycerin, polysorbate 60, carbomer, ethylhexyl isononanoate, aminomethyl propanol, disteareth-75 IPDI, camphor , PEG-7 caprylic/capric glycerides, blue 1

Questions?

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

#1 PHARMACIST
RECOMMENDED
BRAND
BENGAY®
MENTHOL PAIN RELIEVING GEL

cold
therapy
with PRO-COOL® technology

Same technology used
by chiropractors and
physical therapists

COOLING
PAIN RELIEF

Feel it work
on contact!
vanishing scent
NET WT 4 OZ (113g)

INGREDIENTS AND APPEARANCE

BENGAY COLD THERAPY 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0058
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
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Isopropyl Alcohol (UNII: ND2M416302)
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 60 (UNII: CAL22UVI4M)
Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)
Aminomethylpropanol (UNII: LU49E6626Q)
Disteareth-75 Isophorone Diisocyanate (UNII: 5365FJ30SC)
PEG-7 CAPRYLIC/CAPRIC GLYCERIDES (UNII: AO33GZ05NB)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0058-4	1 in 1 CARTON	10/25/2010
1		113 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	10/25/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)