79584-003 63% Alcohol Antibacterial Hand Gel

Antibacterial Hand Gel by

Drug Labeling and Warnings

Antibacterial Hand Gel by is a Otc medication manufactured, distributed, or labeled by Dongguan Xinhui Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL HAND GEL- alcohol gel 
Dongguan Xinhui Cosmetics Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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79584-003 63% Alcohol Antibacterial Hand Gel

Active ingredient

Ethyl Alcohol 63%

Purpose

Antiseptic

Use

Rub hands thoroughly with the gel and allow to dry.

Warnings

Flammable, keep away from
fire and flames.
For external use only.
When using this product:
● Do not get into eyes.
●If contact occurs, rinse eyes
thoroughly with water.
Stop use and seek medical advice
if irritation or redness develops.

Keep out of reach of children

Keep out of reach of children.
If swallowed, get medical help.

Directions

Removes unwanted bacteria from your hands to reduce.
the risk of illness and spreading germs.

Water, Glycerin, Propylene Glycol, Triethanolamine, Carbomer, Fragrances,
Pigment

ANTIBACTERIAL HAND GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79584-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79584-003-02	48 in 1 BOX	07/20/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 79584-003-01	24 in 1 BOX	07/20/2020
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 79584-003-03	144 in 1 BOX	07/20/2020
3		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 79584-003-04	150 in 1 BOX	07/20/2020
4		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 79584-003-05	180 in 1 BOX	07/20/2020
5		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 79584-003-06	192 in 1 BOX	07/20/2020
6		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 79584-003-07	200 in 1 BOX	07/20/2020
7		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 79584-003-08	225 in 1 BOX	07/20/2020
8		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 79584-003-09	240 in 1 BOX	07/20/2020
9		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 79584-003-10	288 in 1 BOX	07/20/2020
10		30 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	07/20/2020	12/10/2022

Labeler - Dongguan Xinhui Cosmetics Co., Ltd. (554539142)

Establishment
Name	Address	ID/FEI	Business Operations
Dongguan Xinhui Cosmetics Co., Ltd.		554539142	manufacture(79584-003)

Revised: 12/2022

Document Id: ef73f80b-d34d-4de0-e053-2a95a90a613d

34390-5

Set id: ab1214d0-a40a-2d10-e053-2995a90ab149

Version: 3

Effective Time: 20221210