BENGAY ZERO DEGREES MENTHOL PAIN RELIEVING- menthol gel
Johnson & Johnson Consumer 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® Zero Degrees

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)

Principal Display Panel - 85 g Container Bag Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58232-4036-1	1 in 1 POUCH	09/15/2011	12/06/2017
1		85 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	09/15/2011	12/06/2017

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 5/2020

Document Id: 119d8dfe-d51d-4d01-9450-ab576eb1137c

Set id: dbdba6b0-814d-4732-91a6-239fbc0ab093

Version: 5

Effective Time: 20200518

Johnson & Johnson Consumer Inc.