ANTISEPTIC- benzalkonium chloride liquid 
Total Resources International

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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Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Uses

Warnings

For external use only

Do not use in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask doctor if irritation or redness develop and persists for more than 72 hours

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

Directions

Inactive ingredients

alcohol, water

PRINCIPAL DISPLAY PANEL – packet label

NDC 55550-200-00

Antiseptic
Towelette

Benzalkonium Chloride/
First Aid Antiseptic

1 SINGLE-USE
PREMOISTENED TOWELETTE

PRINCIPAL DISPLAY PANEL – packet label
ANTISEPTIC 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55550-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
alcohol (UNII: 3K9958V90M)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55550-200-002.5 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/2013
Labeler - Total Resources International (790160535)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(55550-200)

Revised: 7/2013
Document Id: 5e11bc77-c763-455b-bab8-19b0b917a80b
Set id: d1819e40-89ba-41fd-873a-705dfd3d0d48
Version: 2
Effective Time: 20130701
 
Total Resources International