FOAMING ANTIBACTERIAL GREEN- antibacterial green liquid

Foaming Antibacterial Green by

Drug Labeling and Warnings

Foaming Antibacterial Green by is a Otc medication manufactured, distributed, or labeled by Uweport LLC, uweport, Uweport llc, Guangdong Bolicen Bio-Technology Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

1. Isopropyl Alcohol (3%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Chloroxylenol (0.5% w/v).
3. Sodium Laureth Sulfate (6% v/v).
4. Cocamidopropyl Betaine (2% v/v).
5. Decyl Glucoside (1% v/v)
6. Sodium C14-16 Olefin Sulfonate (2% v/v)
7. DMDM Hydantoin (0.3% v/v)
8. Citric Acid (0.015% v/v)
9. PEG-40 Hydrogenated castor oil (0.2% v/v)
10. Sterile distilled water or boiled cold water.

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

Active Ingredient(s)

Chloroxylenol 0.5% w/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

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.

STOP USE

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

Sodium Laureth Sulfate, Isopropyl Alcohol, Cocamidopropyl Betaine, Decyl Glucoside, Sodium C14-16 Olefin Sulfonate, DMDM Hydantoin, Citric Acid, PEG-40 Hydrogenated castor oil, FD&C Blue NO.1, FD&C Yellow NO.5,purified water USP

Package Label - Principal Display Panel

1000 ml NDC: 80401-110-10

INGREDIENTS AND APPEARANCE

FOAMING ANTIBACTERIAL GREEN 
antibacterial green liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80401-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)	2 mL  in 100 mL
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)	6 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)	3 mL  in 100 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	2 mL  in 100 mL
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)	1 mL  in 100 mL
CHLOROCITRIC ACID (UNII: 0W1BY8O77G)	0.015 mL  in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.2 mL  in 100 mL
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.3 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80401-110-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/30/2020

Labeler - Uweport LLC (081252924)

Registrant - uweport (081252924)

Establishment
Name	Address	ID/FEI	Business Operations
Uweport llc		081252924	label(80401-110)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Bolicen Bio-Technology Co Ltd		554525110	manufacture(80401-110)