Rinse-free Hand Sanitizer by Guangzhou Gotdya Fine Chemical Co., Ltd.

Rinse-free Hand Sanitizer by

Drug Labeling and Warnings

Rinse-free 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]

RINSE-FREE 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 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

60 mL NDC: 76591-401-01

Package Label - Principal Display Panel

236 mL NDC: 76591-401-02

Package Label - Principal Display Panel

473 mL NDC: 76591-401-03

Package Label - Principal Display Panel

500 mL NDC: 76591-401-04

Package Label - Principal Display Panel

1000 mL NDC: 76591-401-05

Package Label - Principal Display Panel

3785 mL NDC: 76591-401-06

RINSE-FREE HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76591-401
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)	0.5 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.07 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	24.2 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.23 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76591-401-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/06/2020
2	NDC: 76591-401-02	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/06/2020
3	NDC: 76591-401-03	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/06/2020
4	NDC: 76591-401-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/06/2020
5	NDC: 76591-401-05	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/06/2020
6	NDC: 76591-401-06	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/06/2020	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(76591-401)

Revised: 12/2022

Document Id: effffbf3-8f86-7b7e-e053-2a95a90ad528

34390-5

Set id: ac1e45d5-bc3d-1506-e053-2a95a90af566

Version: 5

Effective Time: 20221217