FIRST AID- benzalkonium chloride and lidocaine cream

First Aid by

Drug Labeling and Warnings

First Aid by is a Otc medication manufactured, distributed, or labeled by Provision Medical, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each gram)

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

• temporary relief of pain associated with minor burns, cuts and scrapes
• 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
• may be covered with a sterile bandage.

Inactive Ingredients

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

Manufactured for:
Provision Medical Products
Palm Desert, CA 92211

Principal Display Panel - Pouch Label

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

cream Relieves Pain and Helps Prevent Infection

First Aid and Burn 0.9g

The Provision
First Aid
Line™

INGREDIENTS AND APPEARANCE

FIRST AID 
benzalkonium chloride and lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-3553
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 (UNII: 98PI200987) (lidocaine - UNII:98PI200987)	lidocaine	5.0 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: 69103-3553-1	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	12/02/2014

Labeler - Provision Medical (036936831)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(69103-3553)