DUANE READE ALOE VERA PAIN RELIEVING- lidocaine gel
DUANE READE 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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Drug Facts

Active Ingredients

Lidocaine 0.50%
Menthol 0.10%

Purpose

Topical Analgesic

Uses

temporary relief of pain and itching
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 if symptoms persists for more than 7 days.
symptoms clear up and occur again within a few days.

Keep out of the 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

Water, Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Glycerin, Polysorbate 20, Carbomer, Triethanolamine, Diazolidinyl urea, Disodium EDTA, Tocopherol, Blue 1.

Principal Display Panel

UNIQUELY NY DRTM SINCE 1960

aloe
vera

pain relieving gel
with Lidocaine and Menthol

NET WT 16 OZ (454 g)

DUANE READE ALOE VERA PAIN RELIEVING
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67732-408
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67732-408-19	454 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/23/2012

Labeler - DUANE READE INC. (011988995)