DUANE READE BURN RELIEF PAIN RELIEVING GEL- lidocaine hydrochloride gel

Duane Reade Burn Relief by

Drug Labeling and Warnings

Duane Reade Burn Relief by is a Otc medication manufactured, distributed, or labeled by DUANE READE INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCl 0.50%

Purpose

Topical Anesthetic

Uses

• temporary pain relief
• helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites.

Warnings

For external use only

Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product

• avoid contact with eyes.

stop use and ask a doctor if

• Conditions worsens or symptoms persists for more than 7 days.
• Symptoms clear up and occur again within a few days.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older.apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Diazolidinyl urea, Disodium EDTA, Menthol, Yellow 5, Blue 1.

Principal Display Panel

UNIQUELY NY DRTM SINCE 1960

burn
relief
pain relieving gel
with Lidocaine
NET WT 8 OZ (227 g)

INGREDIENTS AND APPEARANCE

DUANE READE BURN RELIEF  PAIN RELIEVING GEL
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67732-406
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67732-406-16	226 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/13/2012

Labeler - DUANE READE INC. (011988995)