BAC STOP4A HAND SANITIZER- alcohol solution

BAC STOP4A HAND SANITIZER by

Drug Labeling and Warnings

BAC STOP4A HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by ENVIRO TECH CHEMICAL SERVICES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 80% v/v.

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

• in children less than 2 months of age.
• on open skin wounds.

When using this product keep out of eyes, ears, and 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

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information:

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

Label 59 mL

118 mL Label

177 mL Label

236 mL Label

473 mL Label

946 mL Label

3785 mL (1 gallon)  Label

INGREDIENTS AND APPEARANCE

BAC STOP4A HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66284-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66284-002-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
2	NDC: 66284-002-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
3	NDC: 66284-002-03	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
4	NDC: 66284-002-04	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
5	NDC: 66284-002-05	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
6	NDC: 66284-002-06	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020
7	NDC: 66284-002-07	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/23/2020

Labeler - ENVIRO TECH CHEMICAL SERVICES, INC. (805860483)

Establishment
Name	Address	ID/FEI	Business Operations
ENVIRO TECH CHEMICAL SERVICES, INC.		805860483	manufacture(66284-002)