CLEAN SEPT ALCOHOL ANTISEPTIC 70% - TOPICAL HAND SANITIZER NON-STERILE GEL- ethyl alcohol gel

Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel by

Drug Labeling and Warnings

Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-Sterile Gel by is a Otc medication manufactured, distributed, or labeled by BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Panel - Active Ingredients

Denatured Ethyl Alcohol 70% v/v. Purpose: Antiseptic.

Drug Facts Panel - Purpose

Purpose: Antiseptic.

Drug Facts Panel - Use

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

Drug Facts Panel - 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. If swallowed, get medical help or contact a Poison Control Center right away.

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

Drug Facts Panel - 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.

Drug Facts Panel - Other Information

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

Drug Facts Panel - Inactive Ingredients

Carbomer, Glycerin, Triethanolamine, Water.

Package Label - Principal Display Panel

200 ml, NDC: 79916-001-01

500 ml, NDC: 79916-001-02

1500 ml, NDC: 79916-001-03

5000 ml, NDC: 79916-001-04

3 ml, NDC: 79916-001-05

INGREDIENTS AND APPEARANCE

CLEAN SEPT ALCOHOL ANTISEPTIC 70% - TOPICAL HAND SANITIZER NON-STERILE GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79916-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)	0.18 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.22 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)	0.6 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79916-001-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020
2	NDC: 79916-001-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020
3	NDC: 79916-001-03	1500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020
4	NDC: 79916-001-04	5000 mL in 1 JUG; Type 0: Not a Combination Product	08/06/2020
5	NDC: 79916-001-05	3 mL in 1 POUCH; Type 0: Not a Combination Product	08/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/06/2020

Labeler - BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA (900786538)

Establishment
Name	Address	ID/FEI	Business Operations
BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA		900786538	manufacture(79916-001) , pack(79916-001) , label(79916-001)