SELECT BRAND BURN RELIEF - lidocaine hcl gel
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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 ingredient

Lidocaine HCL 0.50%

Purpose

Topical Anesthetic

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

When using this product

avoid contact with eyes.
do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

condition worsens or if symptoms persist for more than 7 days.
if symptoms clear up and occur again within a few days.

Keep out of reach of children.
If swallowed get medical help or contact Poison Control Center immediately.

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: ask a doctor

Inactive ingredients

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

Principal Display Panel

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the lower price name brand
BURN RELIEF
ALOE VERA GEL
with
LIDOCAINE
COOLS SUNBURN PAIN
NET WT 8 OZ( 227g)

SELECT BRAND BURN RELIEF
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15127-002
Route of Administration	TOPICAL

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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15127-002-16	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	11/19/2012

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