HAND SANITIZER- ethyl alcohol gel

hand sanitizer by

Drug Labeling and Warnings

hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Hangzhou Huiji Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on
the skin.

WARNINGS

Flammable. Keep away from fire or flame.
Do not use
●in children less than 2 months of age
●on open skin wounds
For external use only
When using this product avoid contact with eyes.
If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash
develops and continues for more than 72 hours.

keep out of reach of children

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

Directions

●Take a palmful (5grams) of product in one hand.
●Spread on both hands and rub into skin
until dry (approximately 1 to 2 minutes).
●Supervise children under 6 years of age when
using this product to avoid swallowing.

Other Information

1 Do not store above 105°F
1 May discolor some fabrics

Inactive ingredients

Carbomer, Fragrance, Glycerin, Triethanolamine,
Water,

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73788-105
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)
CARBOMER 934 (UNII: Z135WT9208)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73788-105-01	200 in 1 CARTON	07/15/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 73788-105-02	200 in 1 CARTON	07/15/2020
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 73788-105-03	48 in 1 CARTON	07/15/2020
3		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 73788-105-04	30 in 1 CARTON	07/15/2020
4		355 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 73788-105-05	20 in 1 CARTON	07/15/2020
5		480 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 73788-105-06	20 in 1 CARTON	07/15/2020
6		420 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 73788-105-07	100 in 1 CARTON	07/15/2020
7		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 73788-105-08	4 in 1 CARTON	07/15/2020
8		3780 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 73788-105-09	20 in 1 CARTON	07/15/2020
9		540 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 73788-105-10	200 in 1 CARTON	07/15/2020
10		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/15/2020

Labeler - Hangzhou Huiji Biotechnology Co., Ltd. (526893497)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Huiji Biotechnology Co., Ltd.		526893497	manufacture(73788-105)