Drug Facts

BURN RELIEFPREFERRED PLUS PH PREFERRED PLUS PHARMACY- lidocaine hcl gel
Kinray Inc.

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

Lidocaine HCl 0.50%

Uses

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

Warnings

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

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 ingredients

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

Purpose

Pain Reliever.

Keep out of reach of children.

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

Preferred Plus Pharmacy Burn Relief Aloe Gel with Lidocaine.

Label image

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Kinray Inc. (012574513)