LIDOCAINE- burn relief spray aerosol, spray

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 0.5%

​ ​Purpose

External analgesic

Uses

for the temporary relief of pain and itching associated with:

• sunburn
• minor burns
• minor cuts
• scrapes
• insect bites
• minor skin irritations

Warnings

For external use only.​ Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

​Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

​Do not use

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

• do not get into eyes
• ask a doctor before using on children under 2 years of age

​Stop use and ask a doctor if

• conditions gets worse
• symptoms last more than 7 days or clears up and occurs again in few days

​Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

​Directions

• shake can well
• for adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily
• for children under 2 years of age, ask a doctor
• to apply to face spray in palm of hand and gently apply

​Other information

store between 20º and 25ºC (68ºF and 77º)

​Inactive ingredients

aloe barbadensis gel, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerine, methylparaben, propane, propylene glycol, propylparaben, tocopheryl acetate (vitamin E acetate), triethanolamine, simethicone, water

​ ​Questions?

call 1-866-964-0939

​Principal Display Panel

Premier

Burn Relief Spray

with Aloe

Cool and soothes

Relieves pain with lidocaine

For minor burns, cuts and scrapes

Cools, moisturizes and relieves itching

Net WT 4.5 OZ (127 g)

INGREDIENTS AND APPEARANCE

LIDOCAINE 
burn relief spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.64 g  in 127 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTANE (UNII: 6LV4FOR43R)
CARBOMER 940 (UNII: 4Q93RCW27E)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPANE (UNII: T75W9911L6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-006-45	127 g in 1 CANISTER; Type 1: Convenience Kit of Co-Package	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2013

Labeler - Premier Brands of America Inc. (080051232)