LIDOCAINE- burn relief aerosol, spray

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by LEADER/ Cardinal Health 110, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 0.5%

Purpose

External analgesic

Uses

for temporary relief of pain and itching associated with:

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

Warnings

For external use only.

Flammable:

Use only as directed. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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 clear up and occur again in a few days

Keep out of reach of children.

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

Directions

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

Other information

store between 20°C to 25°C (68° to 77°F)

Inactive ingredients

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

Questions?

Call 1-866-964-0939

Principal Display Panel

Leader

Burn

Relief

Spray

Lidocaine 0.5%

External Analgesic

Relieves Pain &

Itching from

Sunburn, Minor

Burns & Insect Bites

Cools & Moisturizes

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: 70000-0037
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
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPANE (UNII: T75W9911L6)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOMER 940 (UNII: 4Q93RCW27E)
BUTANE (UNII: 6LV4FOR43R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0037-1	127 g in 1 CAN; Type 0: Not a Combination Product	02/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/15/2020

Labeler - Cardinal Health - Leader (097537435)