BURN WITH ALOE- lidocaine hydrochloride spray

Burn with Aloe by

Drug Labeling and Warnings

Burn with Aloe by is a Otc medication manufactured, distributed, or labeled by Provision Medical, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine HCI 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 areas
• near eyes, if this happens rinse thoroughly with water

Stop use and ask a 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 Poison Control Center right away

Directions

• adults and children 2 years of age and older: spray an even layer of burn spray over cleaned 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 - Bottle Label

with aloe vera

BURN SPRAY

Relieves Pain in Minor Burns

Washable

Package Not Child Resistant

2 fl. oz. (59.15ml)

Manufactured for

Provision Medical Products Palm Desert, CA 92211

INGREDIENTS AND APPEARANCE

BURN WITH ALOE 
lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-3500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	200 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)
diazolidinyl urea (UNII: H5RIZ3MPW4)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-3500-1	0.05915 L in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/29/2014

Labeler - Provision Medical (036936831)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(69103-3500)