ANTISEPTIC WIPES- alcohol, benzalkonium chloride cloth 
D&A USA, LLC

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 INGREDIENTS

Ethyl alcohol 15%. Purpose: Antiseptic

Benzalkonium Chloride 0.1%. Purpose: Antiseptic

PURPOSE

Antiseptic

WARNINGS

DO NOT USE

on children less than three years old and on skin wounds.

WHEN USING THIS PRODUCT

Keep out of eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin.

STOP USE AND ASK A DOCTOR IF

irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

USES

OTHER INFORMATION

Store at room temperature, avoid sunlight irradiating.

INACTIVE INGREDIENTS

Water, Cetylpyridinium chloride, Chlorphenesin, Biguanide, Propylene glycol

INGREDIENTS AND APPEARANCE

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

72 PCS NDC: 80168-001-01

D&A USA

CONTAINS

75% ALCOHOL STOSTE

ANTISEPTIC WIPES

for hand cleaning

72 Wipes

7.87 x 5.51 in (20 x 14 cm)

package label

ANTISEPTIC WIPES 
alcohol, benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80168-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL15 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BIGUANIDE (UNII: FB4Q52I9K2)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80168-001-0172 in 1 BAG09/13/2020
1320 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/13/2020
Labeler - D&A USA, LLC (117661331)

Revised: 9/2020
Document Id: aefd54bc-470c-d591-e053-2995a90a08ed
Set id: aefd6359-c155-4bfa-e053-2a95a90aa78d
Version: 1
Effective Time: 20200913
 
D&A USA, LLC