AFASSCO FIRST AID BURN CREAM- lidocaine hydrochloride, benzalkonium chloride ointment

Afassco First Aid Burn Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride  0.13%
Lidocaine HCL   0.5%

PURPOSE

Purpose  First aid antiseptic., external amalgesic

INDICATIONS & USAGE

Uses

first aid to help prevent
infection and for the
temporary relief of pain and
itching associated with minor
cuts, scrapes, burns

WARNINGS

Warnings

For external use only

Do not use ■ in eyes ■ in

large quantities, over raw

blistered areas, on deep

puncture wounds, animal

bites or serious burns ■ for

more than one wek

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If ingested, contact a  Poison

Control Center right away.

DOSAGE & ADMINISTRATION

Directions 

■ clean affected area ■ apply

a small amount on area, not

more than 3 times daily

■ may cover with a sterile bandage

OTHER SAFETY INFORMATION

Other Information

store at room temperature

INACTIVE INGREDIENT

Inactive Ingredients

Peregal-O 2.5%, Glycerin

Monostearate 2.5%, Glycerol

5%, Purified Water

PRINCIPAL DISPLAY PANEL

↓Principal Display 6 ct. Package↓

Afassco¦ ¦®

The First Choice

in First Aid

FIRST AID/BURN CREAM

No.339              6 ct.

6 ct.

FIRST AID/
BURN CREAM

ANSI Z308.1

Manufactured for Afassco, Inc., Minden, NV 89423

6 70254 20339 9

↓Principal Display 25 ct. Package↓

↓1 gm Packet↓

res

INGREDIENTS AND APPEARANCE

AFASSCO FIRST AID BURN CREAM 
lidocaine hydrochloride, benzalkonium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51532-4622
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.005 g  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51532-4622-1	6 in 1 BOX	12/07/2018
1		1 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 51532-4622-2	25 in 1 BOX	12/07/2018
2		1 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	part348	12/07/2018

Labeler - Afassco Inc. (609982723)

Registrant - Afassco Inc. (956159800)