75% Alcohol Hand Sanitizer by Guangzhou Gotdya Fine Chemical Co., Ltd.

75% Alcohol Hand Sanitizer by

Drug Labeling and Warnings

75% Alcohol 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]

75% ALCOHOL HAND SANITIZER- hand sanitizer spray 
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 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 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 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.

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

sterile distilled water.

Package Label - Principal Display Panel

118 mL NDC: 76591-701-01

75% ALCOHOL HAND SANITIZER 
hand sanitizer spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76591-701
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
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76591-701-01	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2021	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(76591-701)

Revised: 12/2022

Document Id: f04e1125-3006-f971-e053-2a95a90a2f1e

34390-5

Set id: c08ca95e-be0a-ed71-e053-2a95a90abcba

Version: 2

Effective Time: 20221220