Burn (Lidocaine Hydrochloride) Spray [First Aid Only, Inc] -

BURN (LIDOCAINE HYDROCHLORIDE) SPRAY [FIRST AID ONLY, INC]
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NDC	62985-5082-1
Set ID	eaf73161-8597-4575-8b0f-be3e3389e5cc
Category	HUMAN OTC DRUG LABEL
Packager	First Aid Only, Inc
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

Lidocaine HCL 2.0%
Purpose

Topical Pain Relief
Uses

temporary pain relief associated with minor burns
Warnings
For external use only.
Do not use
- In large quantities, particularly over raw or blistered area
- Near eyes, if this happens rinse thoroughly with water
Stop use and ask doctor if condition worsens or persists for more than 7 days or clears up and returns

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; spray an even layer of burn spray over affected area not more than 3-4 times daily
- For children under 2 years of age, consult a physician.
Inactive ingredients

aloe vera, germaben II. Propylene glycol, purified water
PRINCIPAL DISPLAY PANEL

Burn Spray

Pain relieving spray for use on minor burns.

M5082

3 fl. oz. (88.7 ml.)
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FIRST AID ONLY

Distributed by First Aid Only, Inc.

Vancouver, WA 96882 USA

INGREDIENTS AND APPEARANCE

BURN
lidocaine hydrochloride spray

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	20 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
aloe vera leaf (UNII: ZY81Z83H0X)
propylene glycol (UNII: 6DC9Q167V3)
diazolidinyl urea (UNII: H5RIZ3MPW4)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62985-5082-1	0.0887 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/13/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/13/2014

Labeler - First Aid Only, Inc (196551634)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(62985-5082)

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