FIRST AID AND BURN- benzalkonium chloride, lidocaine hydrochloride cream

First Aid and Burn by

Drug Labeling and Warnings

First Aid and Burn by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation, Safetec of America, Inc.. 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

First Aid Antiseptic

External analgesic

Uses

first aid to help prevent infection and for the temporary relief of itching associated with

• minor cuts
• scrapes
• burns

Warnings

For external use only

Do not use

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

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

When using this product avoid contact with eyes

Stop use and ask a doctor if

• condition worsens or persists for more than 7 days
• clears up and occurs again within a few days

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 of age and older:
• clean the affected area
• apply a small amount of this product to the area 1 to 3 times daily
• may be covered with a sterile bandage
• children under 2 years of age: consult a doctor

Other information

• store at room temperature
• do not use if packet is opened or torn

Inactive ingredients

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

Questions? 1-800-835-2263

REORDER
www.PhysiciansCareFirstAid.com
1 800 835 2263

Principal Display Panel - Packet Label

FIRST AID ONLY®

Burn Cream

NET WT 1/32 oz (0.9g)

© 2015 Acme United Corporation.

Faifield, CT 06824

1.800.835.2263

www.FirstAidOnly.com

NDC: 0924-5701-01

Principal Display Panel - Packet Label

FIRST AID ONLY®

13-006

BURNS

First Aid/Burn Cream

12 (0.9g) Packets

Ungüento de primeros auxilios/para quemaduras

12 sobres de (0.9g)

NDC: 0924-5701-10

INGREDIENTS AND APPEARANCE

FIRST AID AND BURN 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5701
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
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: 0924-5701-04	10 in 1 BOX
1	NDC: 0924-5701-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-5701-09	10 in 1 BOX
2	NDC: 0924-5701-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0924-5701-10	12 in 1 BOX
3	NDC: 0924-5701-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0924-5701-11	25 in 1 BOX
4	NDC: 0924-5701-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 0924-5701-12	144 in 1 BOX
5	NDC: 0924-5701-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 0924-5701-13	60 in 1 BOX
6	NDC: 0924-5701-01	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	part333A	01/27/2012

Labeler - Acme United Corporation (001180207)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(0924-5701)