Rite Aid Burn Relief (Lidocaine Hydrochloride) Gel [Rite Aid Corporation] -

RITE AID BURN RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [RITE AID CORPORATION]
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NDC	11822-9009-6
Set ID	bc33d1a5-71d3-45af-aa5a-879375880ffc
Category	HUMAN OTC DRUG LABEL
Packager	RITE AID CORPORATION
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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Active Ingredient

Lidocaine HCl 0.50%
Purpose

Topical Anesthetic
Uses
- temporary pain 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 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

RITE AID
BURN RELIEF
ALOE VERA GEL
Cools and Relieves Sunburn Pain
with LIDOCAINE
NET WT 8 OZ (227 g)

INGREDIENTS AND APPEARANCE

RITE AID BURN RELIEF
lidocaine hydrochloride gel

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

Ingredient Name	Strength
Inactive Ingredients
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-9009-6	226 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	12/03/2012

Labeler - RITE AID CORPORATION (014578892)

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Medic