79584-002 68% Alcohol Hand Sanitizer

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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79584-002 68% Alcohol Hand Sanitizer

Active ingredient

Alcohol 68%

Purpose

Antiseptic

Use

Decreases bacteria on hands

Warnings

For external use only
flammable, keep away from fire or flame
Stop use and ask a doctor if irritation and redness develop.

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 a 'palmful' of product in one hand
spread on both hands and rub the skin until dry

water, glycerol, propylene glycol, carbomer,
triethanolamine

ANTIBACTERIAL HAND GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79584-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 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)

Product Characteristics
Color	yellow, purple, pink, blue, green	Score
Shape		Size
Flavor	LEMON, STRAWBERRY, KIWI, GRAPE, BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79584-002-02	60 in 1 BOX	07/15/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 79584-002-01	72 in 1 BOX	07/15/2020
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 79584-002-03	72 in 1 BOX	07/15/2020
3		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 79584-002-04	24 in 1 BOX	07/15/2020
4		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 79584-002-05	200 in 1 BOX	07/15/2020
5		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 79584-002-06	200 in 1 BOX	07/15/2020
6		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 79584-002-07	100 in 1 BOX	07/15/2020
7		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 79584-002-08	100 in 1 BOX	07/15/2020
8		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 79584-002-09	48 in 1 BOX	07/15/2020
9		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 79584-002-10	24 in 1 BOX	07/15/2020
10		500 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	12/10/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
Dongguan Xinhui Cosmetics Co., Ltd.		554539142	manufacture(79584-002)

Revised: 12/2022

Document Id: ef73e98d-5112-efe3-e053-2a95a90a5ee5

34390-5

Set id: aa84d0c0-2b11-5a52-e053-2a95a90adff9

Version: 4

Effective Time: 20221210