Alcohol Gel Hand Sanitizer by Guangzhou Gotdya Fine Chemical Co., Ltd.

Alcohol Gel Hand Sanitizer by

Drug Labeling and Warnings

Alcohol Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Guangzhou Gotdya Fine Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL GEL HAND SANITIZER- hand sanitizer gel 
Guangzhou Gotdya Fine Chemical 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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Active Ingredient(s)

Ethyl alcohol 76% v/v. Purpose: Antimicrobial

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

• Place enough product on hands cover all surfaces. Rub hands together until dry
• Supersive 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

glycerin, hydrogen peroxide, purified water USP.

Package Label - Principal Display Panel

2000 mL NDC: 76591-801-01

ALCOHOL GEL HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76591-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	76 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76591-801-01	2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/08/2021	12/31/2022

Labeler - Guangzhou Gotdya Fine Chemical Co., Ltd. (551470189)

Registrant - Guangzhou Gotdya Fine Chemical Co., Ltd. (551470189)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Gotdya Fine Chemical Co., Ltd.		551470189	manufacture(76591-801)

Revised: 12/2022

Document Id: f000256d-8811-498a-e053-2995a90a05aa

34390-5

Set id: d195bf7d-01f2-907e-e053-2a95a90afebc

Version: 2

Effective Time: 20221217