BENGAY ULTRA STRENGTH REGULAR SIZE- menthol patch

Bengay Ultra Strength by

Drug Labeling and Warnings

Bengay Ultra Strength by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, 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 minor aches and pains of muscles and joints associated with:
  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

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

Directions

• open pouch and remove patch
• if desired, cut patch to size
• peel off protective backing and apply sticky side to affected area
• 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: consult a doctor

Other information

• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

calcined kaolin, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, polyacrylic acid, polysorbate 80, propylparaben, silica, sodium polyacrylate, sodium polyacrylate starch, sorbitan oleate, sorbitol, tartaric acid, titanium dioxide, water

Questions?

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

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Dist: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL - 5 Pouch Carton

ULTRA STRENGTH
BENGAY®
PAIN RELIEVING PATCH
Menthol Topical Analgesic Patch

• POWERFUL PAIN RELIEF
• DEEP, PENETRATING HEAT
• LONG LASTING, UP TO 8 HOURS

REGULAR SIZE
Good for Neck to Arm

5 INDIVIDUALLY SEALED PATCHES
3.9 in × 5.5 in (10 cm × 14 cm)

INGREDIENTS AND APPEARANCE

BENGAY ULTRA STRENGTH   REGULAR SIZE
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-6000
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

Inactive Ingredients
Ingredient Name	Strength
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylparaben (UNII: Z8IX2SC1OH)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Sorbitol (UNII: 506T60A25R)
Tartaric Acid (UNII: W4888I119H)
Titanium Dioxide (UNII: 15FIX9V2JP)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-6000-5	5 in 1 CARTON	09/01/2012
1		1 in 1 POUCH; 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	09/01/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)