EXCHANGE SELECT BURN RELIEF PAIN RELIEVING- lidocaine hydrochloride gel

Exchange Select Burn Relief by

Drug Labeling and Warnings

Exchange Select Burn Relief by is a Otc medication manufactured, distributed, or labeled by ARMY AND AIR FORCE EXCHANGE SERVICE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCl 0.50%

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 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

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

Principal Display Panel

exchange

select

X

BURN RELIEF

Pain Relieving Gel

with
Lidocaine
Cools, Soothes and
Relieves Sunburned Skin

NET WT 8 OZ (227 g)

INGREDIENTS AND APPEARANCE

EXCHANGE SELECT BURN RELIEF  PAIN RELIEVING
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-044
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: 55301-044-16	227 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	11/15/2012

Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)