Duane Reade Aloe Vera Pain Relieving (Lidocaine) Gel [Duane Reade Inc.] -

DUANE READE ALOE VERA PAIN RELIEVING (LIDOCAINE) GEL [DUANE READE INC.]
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NDC	67732-408-19
Set ID	d227f447-e129-4c34-8300-d00580e61daa
Category	HUMAN OTC DRUG LABEL
Packager	DUANE READE INC.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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)

INGREDIENTS AND APPEARANCE

DUANE READE ALOE VERA PAIN RELIEVING
lidocaine gel

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)

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Medic