BURN RELIEFPREFERRED PLUS PH PREFERRED PLUS PHARMACY- lidocaine hcl gel

Burn ReliefPreferred Plus Ph by

Drug Labeling and Warnings

Burn ReliefPreferred Plus Ph by is a Otc medication manufactured, distributed, or labeled by Kinray Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 0.50%

INDICATIONS & USAGE

Uses

Temporarily relief of pain and itching due to:  sunburn, minor burns, insect bites, cuts, and scrapes.

WARNINGS

Warnings

For external use only.  Avoid contact with eyes.  If symptoms persist for more than 7 days, discontinue use and consult a physician.

DOSAGE & ADMINISTRATION

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:  consult a physician.

INACTIVE INGREDIENT

Inactive ingredients

Aloe Vera Gel, Water, Propylene Glycol, Glycerin, Triethanolamine, Isopropyl Alcohol, Polysorbate, Carbomer, Diazolidinyl Urea, Menthol, Disodium EDTA, Yellow 5, Blue 1.

PURPOSE

Purpose

Pain Reliever.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

Preferred Plus Pharmacy Burn Relief Aloe Gel with Lidocaine.

INGREDIENTS AND APPEARANCE

BURN RELIEFPREFERRED PLUS PH  PREFERRED PLUS PHARMACY
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Aloe (UNII: V5VD430YW9)
Isopropyl Alcohol (UNII: ND2M416302)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
Menthol (UNII: L7T10EIP3A)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)
Edetate Disodium (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-022-08	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	03/15/2013

Labeler - Kinray Inc. (012574513)