FIRST AID- benzalkonium chloride and lidocaine cream 
Provision Medical

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each gram)

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

Warnings

For external use only

Do not use

Keep out of reach of children If ingested contact a Poison Control Center right away.

Directions

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™

Principal Display Panel - Pouch Label
FIRST AID 
benzalkonium chloride and lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3553
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1.3 mg  in 1 g
lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987) lidocaine5.0 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-3553-10.9 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/02/2014
Labeler - Provision Medical (036936831)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-3553)

Revised: 12/2014
Document Id: 82d0a229-1c96-43b2-9f8c-44af83fae748
Set id: a29ed953-2584-48f9-a1a2-930157f0c60c
Version: 1
Effective Time: 20141202
 
Provision Medical