LIDOCAINE- burn relief aerosol, spray

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Fred’s Stores of Tennessee, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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.

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

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

Keep out of reach of children.

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

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 (68º and 77ºF)

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 1-888-423-0139

Principal Display Panel

Fred's

Burn Relief Spray

LIDOCAINE 0.5%

External Analgesic

COOLING

Relieves pain and itching from sunburn, minor burns and insect bites

Cools, moisturizes and soothes sunburned skin

NET WT 4.5 OZ (127 g)

INGREDIENTS AND APPEARANCE

LIDOCAINE 
burn relief aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-374
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 934 (UNII: Z135WT9208)
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: 55315-374-45	127 g in 1 CAN; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/19/2017

Labeler - Fred’s Stores of Tennessee, Inc (005866116)