BURN WITH LIDOCAINE- benzalkonium chloride, lidocaine hydrochloride cream

Burn with Lidocaine by

Drug Labeling and Warnings

Burn with Lidocaine by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

Topical antiseptic

Topicall analgesic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relief of pain and itching associated with:

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

Warnings

For external use only.

Do not use

• in the eyes
• over large areas of the body or on deep puncture wounds, animal bites, or serious burns
• in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

• the condition gets worse
• condition clears up and recurs within a few days
• condition persists for more than 7 days

If pregnant or breast feeding,

ask a health care professional before use.

Keep out of reach of children.

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

Directions

Adults and children 2 years and over:

• clean the affected area
• apply a small amount of this product on the area 3 to 4 times daily
• may be covered with a sterile bandage

Children under 12 years:

• consult a doctor

Children under 2 years

• consult a doctor

Other information

• store in a cool, dry area 59° to 79°F (15° to 25°C)
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Questions or comments?

1-800-634-7680

MF Burn Cream with Lidocaine Label

MEDI-FIRST®

BURN CREAM with Lidocaine

Product # 20669

NET CONTENTS: 10 Units of 0.9gm

INGREDIENTS AND APPEARANCE

BURN WITH LIDOCAINE 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-260-73	25 in 1 BOX	01/24/2012
1	NDC: 47682-260-99	0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-260-12	10 in 1 BOX	07/03/2017
2		0.9 g in 1 PACKET; 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	01/24/2012

Labeler - Unifirst First Aid Corporation (832947092)