LIDOCAINE- burn relief aerosol, spray

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Foodhold USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 0.5%

Purpose

External analgesic

Uses

for temporary relief of pain and itching associated with:

• sunburn
• minor burns
• minor cuts
• insect bites
• scrapes
• 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 120ºF. Intentional misuse by delibrately concentrating and inhaling the contents can be harmul 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 Control 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 20º to 25ºC (68º to 77ºF)

Inactive ingredients

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

Questions?

Call 1-866-964-0939

Principal Display Panel

CareOne

Burn Relief Spray

Lidocaine

Relieves Pain and Itching from Sunburn, Minor Burns and Insect Bites

Cools, Moisturizes and Soothes Sunburned Skin

NET WT 4.5 OZ (127g)

INGREDIENTS AND APPEARANCE

LIDOCAINE 
burn relief aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-162
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 COPOLYMER TYPE A (UNII: 71DD5V995L)
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)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-162-45	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 - Foodhold USA (809183973)