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 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

Topical Analgesic

Uses

• temporary relief of pain associated with minor burns
• helps protect against harmful bacteria

Warnings

For external use only

Do not use

• in eyes
• in large quantities
• over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
• for more than one week unless directed by a doctor

Keep out of reach of children.

If ingested contact a Poison Control Center right away.

Directions

• clean affected area
• apply small amount not more than 3 times daily
• children under 2: consult a doctor

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL – 0.9 gram packet

NDC: 61010-5701-03

Safetec

First Aid &
Burn Cream

0.9 g (1/32 oz.)

Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077

PRINCIPAL DISPLAY PANEL – 144 count box

NDC: 61010-5701-4

Safetec

First Aid

First Aid & Burn Cream

• For Temporary Relief of
  Pain Associated with
  Minor Burns
• Helps Protect Against
  Harmful Bacteria

Reorder No. 53410
To reorder:
Call: 1-800-456-7077
Fax: 716-895-2969
Online: www.safetec.com

Principal Display Panel – 10 Packet Box Label

Safetec®

FIRST AID

Burn Cream

Quickly soothes pain caused by minor burns
and protects against infection

10 Packets

Each Packet Net. Wt. 0.9g

Made in USA

Reorder No. 53408

INGREDIENTS AND APPEARANCE

FIRST AID AND BURN 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-5701
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: 61010-5701-4	144 in 1 BOX	09/21/2012
1	NDC: 61010-5701-3	0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 61010-5701-5	25 in 1 BOX	09/21/2012
2	NDC: 61010-5701-3	0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 61010-5701-6	10 in 1 BOX	04/01/2020
3	NDC: 61010-5701-3	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	09/21/2012

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-5701)