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

Drug Details [pdf]

75% ALCOHOL 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.

----------

Active Ingredient(s)

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

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 immediately.

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 (59-86)
Avoid freezing and excessive heat

Inactive ingredients

aloe, carbomer, fragrance, propylene glycol, triethanolamine, Vitamin E, water.

Package Label - Principal Display Panel

50 mL NDC: 76591-102-01 Package Label

Package Label - Principal Display Panel

60 mL NDC: 76591-102-02 Package Label

Package Label - Principal Display Panel

100 mL NDC: 76591-102-03 Package Label

Package Label - Principal Display Panel

237 mL NDC: 76591-102-04 Package Label

Package Label - Principal Display Panel

1000 mL NDC: 76591-102-06 Package Label

Package Label - Principal Display Panel

500 mL NDC: 76591-102-05 package label

75% ALCOHOL HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76591-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)	0.18 mL in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.5 mL in 100 mL
ALOE (UNII: V5VD430YW9)	0.02 mL in 100 mL
TOCOPHEROL (UNII: R0ZB2556P8)	0.01 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.35 mL in 100 mL
WATER (UNII: 059QF0KO0R)	23.44 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 76591-102-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2020
2	NDC: 76591-102-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2020
3	NDC: 76591-102-03	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2020
4	NDC: 76591-102-04	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2020
5	NDC: 76591-102-05	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2020
6	NDC: 76591-102-06	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/25/2020	12/31/2022

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Gotdya Fine Chemical Co., Ltd.		551470189	manufacture(76591-102)

Revised: 12/2022

Document Id: f0001ac6-9709-db8d-e053-2995a90a34b7

Set id: ad9db9bc-56bc-3d5a-e053-2995a90aa0ea

Version: 3

Effective Time: 20221217