FIRST AID AND BURN- benzalkonium chloride, lidocaine cream

First Aid and Burn by

Drug Labeling and Warnings

First Aid and Burn by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram):

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

PURPOSE

Purpose:

Topical Antiseptic

Topical Anesthetic

INDICATIONS & USAGE

Uses: Temporary relief of pain and to help prevent infection in

• minor cuts
• scrapes
• burns

WARNINGS

Warnings: For external use only. See a doctor immediately for serious burns

DO NOT USE

Do not use:

• in or near the eyes
• over large portions of the body
• in large quantities particularly over raw surfaces or blistered areas
• longer than 7 days unless directed by a doctor
• more than 1 to 3 times daily

ASK DOCTOR

Ask a doctor before use if you have

• serious burns
• animal bites
• deep or puncture wounds

STOP USE

Stop use and ask a doctor if

• condition lasts for more than 7 days
• condition worsens
• symptoms clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

DOSAGE & ADMINISTRATION

Directions: do not use more than directed

Adults and children 2 years of age and over:

• clean the affected area
• apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
• may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Aloe Vera, Cetyl Alcohol, Diazolidinyl Urea, Edetate Disodium, Glycerin, Clyceryl Monostearate, Methylparaben, Mineral Oil, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID AND BURN 
benzalkonium chloride, lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.13 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	.5 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0037-1	6 in 1 BOX, UNIT-DOSE	07/14/2000
1		.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0037-6	10 in 1 BOX, UNIT-DOSE	07/14/2000
2		.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 50332-0037-2	25 in 1 BOX, UNIT-DOSE	07/14/2000
3		.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 50332-0037-4	144 in 1 BOX, UNIT-DOSE	07/14/2000
4		.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 Drug	M	07/14/2000

Labeler - HART Health (069560969)