ANTIBACTERIAL FREE GEL- alcohol liquid

Antibacterial free gel by

Drug Labeling and Warnings

Antibacterial free gel by is a Otc medication manufactured, distributed, or labeled by Guangzhou Xin Qi Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. WATER
3. CARBOMER
4. TRIETHANOLAMINE

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)

Alcohol 75% v/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

WATER
CARBOMER
TRIETHANOLAMINE

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL FREE GEL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78370-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78370-101-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78370-101-02	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78370-101-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 78370-101-04	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 78370-101-05	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 78370-101-06	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 78370-101-07	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 78370-101-08	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC: 78370-101-09	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC: 78370-101-10	10000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC: 78370-101-11	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
12	NDC: 78370-101-12	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
13	NDC: 78370-101-13	1500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
14	NDC: 78370-101-14	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
15	NDC: 78370-101-15	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
16	NDC: 78370-101-16	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
17	NDC: 78370-101-17	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
18	NDC: 78370-101-18	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
19	NDC: 78370-101-19	8 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
20	NDC: 78370-101-20	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
21	NDC: 78370-101-21	3 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	part333A	03/30/2020

Labeler - Guangzhou Xin Qi Cosmetics Co., Ltd. (403016583)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Xin Qi Cosmetics Co., Ltd.		403016583	manufacture(78370-101)