Burn Reliefpreferred Plus Ph Preferred Plus Pharmacy (Lidocaine Hcl) Gel [Kinray Inc.] -

BURN RELIEFPREFERRED PLUS PH PREFERRED PLUS PHARMACY (LIDOCAINE HCL) GEL [KINRAY INC.]
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NDC	61715-022-08
Set ID	cfddaef0-bb06-4eba-a7bd-bf9ca3036391
Category	HUMAN OTC DRUG LABEL
Packager	Kinray Inc.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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

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)

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