ANTISEPTIC WIPES- alcohol, benzalkonium chloride cloth

Antiseptic Wipes by

Drug Labeling and Warnings

Antiseptic Wipes by is a Otc medication manufactured, distributed, or labeled by D&A USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl alcohol 15%. v/v

Benzalkonium Chloride 0.1%. v/v

Purpose

Antiseptic

Warnings

• For external use only.

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

• Open lid, gently pull back resealable label, remove and use wipe as required.
• Reseal back after use to avoid evaporation of alcohol.
• Discard after single use Required dispose of used wipe in trash receptable.
• Do not flush.

Uses

• For hand washing to decrease bacteria on the skin.
• Apply topically to the skin to help prevent cross contamination.

Other information

Store at room temperature, avoid sunlight irradiating.

Inactive ingredients

Water, Cetylpyridinium chloride, Chlorphenesin, Biguanide, Propylene glycol

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTISEPTIC WIPES 
alcohol, benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80956-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	15 mL  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BIGUANIDE (UNII: FB4Q52I9K2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80956-001-01	72 in 1 BAG	10/28/2020
1		5.6 g in 1 PATCH; 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	10/28/2020

Labeler - D&A USA, LLC (117661331)