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

Hand Sanitizer by

Drug Labeling and Warnings

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]

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)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

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 now.

Directions

• Place enough product in your palm to cover hands and rub hands together briskly until dry.
• Children should be supervised when using hand sanitizer.

Other information

• Store between 15-40C (59-104F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

aminomethyl propanol, carbomer, propylene glycol, sterile distilled water.

Package Label - Principal Display Panel

30 mL NDC: 76591-402-01

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76591-402
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76591-402-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/09/2021	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(76591-402)

Revised: 12/2022

Document Id: f04e2599-6ee9-0ba0-e053-2995a90a5cdb

34390-5

Set id: bd164179-c7a1-3436-e053-2995a90a8a69

Version: 4

Effective Time: 20221220