SANITIZER ACE-SA001- benzalkonium chloride liquid

SANITIZER by

Drug Labeling and Warnings

SANITIZER by is a Otc medication manufactured, distributed, or labeled by ACE CHEM SOLUTIONS, ACE CHEMS SOLUTIONS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This sanitizer is manufactured using only the following United States Pharmacopoei (USP) grade ingredients in the preparation of the product (percentage in the final product formulation) consistent with World Health Organization (WHO):

Belzankonium Chloride (0.2% volume/volume (v/v)) in an aqueous solution).

Alcohol (isopropylic alcohol) (10% v/v)

Sterile distilled water or boiled cold water.

This firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

ACTIVE INGREDIENT

Benzalkonium Chloride. Purpose: Antiseptic

PURPOSE

Antiseptic, Hands, Surface and Cloths Sanitizer.

INDICATIONS & USAGE

Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water ar not available.

WARNINGS

For external use only.

DO NOT USE

in children less than 2 months of age

on open skin wounds

WHEN USING

When using this product keep out eyes, ears, mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious conditions.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Place enough product on hands or surfaces to cover all. Rub hands together untill dry.

Supervise children under 6 years of age when using this products to avoid swallowing.

STORAGE AND HANDLING

Store between 15-30C (59-86F)

Avoiding freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Isopropylic Alcohol, purified water USP.

PRINCIPAL DISPLAY PANEL

250 ml NDC: 77308-003-01

1 L NDC: 77308-003-03

4 L NDC: 77308-003-04

INGREDIENTS AND APPEARANCE

SANITIZER  ACE-SA001
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77308-003
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	2 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)	0.1 L  in 1 L
WATER (UNII: 059QF0KO0R)	0.899 L  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77308-003-01	0.25 L in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
2	NDC: 77308-003-03	1 L in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020
3	NDC: 77308-003-04	4 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/29/2020

Labeler - ACE CHEM SOLUTIONS (951577314)

Establishment
Name	Address	ID/FEI	Business Operations
ACE CHEMS SOLUTIONS		951577314	manufacture(77308-003)