HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Boss (Huizhou) Medical & Health Products Co., Ltd., Hans Manufacturer Inc.. 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 ingredients in the preparation of the product (percentage in final product formulation):

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, 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. Glycerol (0.5% v/v).
3. Carbomer (0.3% v/v).
4. Triethanolamine (0.3% v/v).
5. Aloe Barbadensis Leaf Extract (0.2% v/v)
6. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients.

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

purified water USP, glycerin, carbomer, triethanolamine, aloe barbadensis leaf juice

Package Label - Principal Display Panel

30 mL NDC: 77313-975-11

60 mL NDC: 77313-975-12

100 mL NDC: 77313-975-13

200 mL NDC: 77313-975-14

250 mL NDC: 77313-975-15

300 mL NDC: 77313-975-16

350 mL NDC: 77313-975-17

500 mL NDC: 77313-975-18

1000 mL NDC: 77313-975-19

1500 mL NDC: 77313-975-20

3785 mL NDC: 77313-975-21

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77313-975
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
TROLAMINE (UNII: 9O3K93S3TK)	0.3 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.2 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77313-975-13	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/14/2020
2	NDC: 77313-975-14	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/14/2020
3	NDC: 77313-975-15	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/14/2020
4	NDC: 77313-975-16	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/14/2020
5	NDC: 77313-975-17	350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/14/2020
6	NDC: 77313-975-18	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/14/2020
7	NDC: 77313-975-19	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/14/2020
8	NDC: 77313-975-20	1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/14/2020
9	NDC: 77313-975-21	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/14/2020
10	NDC: 77313-975-11	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
11	NDC: 77313-975-12	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/14/2020

Labeler - Boss (Huizhou) Medical & Health Products Co., Ltd. (554530185)

Registrant - Hans Manufacturer Inc. (787300008)

Establishment
Name	Address	ID/FEI	Business Operations
Boss (Huizhou) Medical & Health Products Co., Ltd.		554530185	manufacture(77313-975) , pack(77313-975) , label(77313-975)