SURESAFE ANTIBACTERIAL WIPES- benzalkonium chloride cloth

SureSafe ANTIBACTERIAL WIPES by

Drug Labeling and Warnings

SureSafe ANTIBACTERIAL WIPES by is a Otc medication manufactured, distributed, or labeled by QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium Chloride 0.10%

Purpose

Antiseptic

Uses:

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Directions:

Adults and Children over 2 years:
Thoroughly clean hands or affected area and discard in waste. Do not flush. Allow to dry without wiping.

Cautions and Warnings:

For external use only. Keep out of reach of eyes. If contact occurs, rinse thoroughly with water. Do not use if you are allergic to any of the ingredients. Discontinue use if irritation or redness develops and if condition persists for more than 72 hours consult a physician. 

Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information:

Store at room temperature

Inactive ingredients:

Water, Citric Acid, Glycerol, Propanediol, Aloe Vera Extract, Hexadecyl Pyridinium Chloride, Iodopropynyl butylcarbamate

Questions:

1-800-215-2516

SPL UNCLASSIFIED SECTION

KILLS 99.9% OF GERMS AND BACTERIA

√ Alcohol - Free

√ Safe on Hands

Designed in USA | Made In China

Distributed By:

EDC Holdings INC

www.SureSafeSupplies.com

Packaging

INGREDIENTS AND APPEARANCE

SURESAFE ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80671-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80671-003-80	1 in 1 PAIL	02/28/2021
1		800 in 1 BAG
1		4.6 mL in 1 PACKAGE; 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	02/28/2021

Labeler - QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD (554548985)

Establishment
Name	Address	ID/FEI	Business Operations
QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD		554548985	manufacture(80671-003)