BURN TREATMENT- benzalkonium chloride, lidocaine hydrochloride cream

Burn Treatment by

Drug Labeling and Warnings

Burn Treatment by is a Otc medication manufactured, distributed, or labeled by CMC Group Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

First aid antiseptic

Pain relieving cream

Uses

• First aid to help prevent infection in minor cuts, scrapes, and burns.
• For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes

Warnings

For external use only.

Do not use

in the eyes  over large areas of the body in large quantities over raw surfaces or blistered areas longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds animal bites serious burns.

Stop use and ask a doctor if

the condition persists or gets worse symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reah of children.

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

Directions

• Clean the affected area
• Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
• Children under 2 years of age: consult a doctor
• May be covered with a sterile bandage

Other information

Store at room temperature

Inactive ingredients

glycerin monostearate, glycerol, purified water

Package Labeling:

INGREDIENTS AND APPEARANCE

BURN TREATMENT 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49687-0014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49687-0014-0	10 in 1 KIT	08/06/2016
1		0.9 g in 1 POUCH; 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	part333A	08/06/2016

Labeler - CMC Group Inc. (005583328)