Hand Sanitizer gel by Guangzhou Opseve Cosmetics Co., Ltd

Hand Sanitizer gel by

Drug Labeling and Warnings

Hand Sanitizer gel by is a Otc medication manufactured, distributed, or labeled by Guangzhou Opseve Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL- hand sanitizer gel 
Guangzhou Opseve Cosmetics 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 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

• Take appropriate amount in your palm then cover all surfaces of your hands and rub them together until they feel dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Sealed, stored in a cool, dry place, away from direct sunlight.

Inactive ingredients

carbomer, fragrance, glycerin, triethanolamine, water.

Package Label - Principal Display Panel

98 mL NDC: 77900-2022-1

Package Label - Principal Display Panel

237 mL NDC: 77900-2022-2

HAND SANITIZER GEL 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77900-2022
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
GLYCERIN (UNII: PDC6A3C0OX)	0.4 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.1085 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	23.8915 mL  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E)	0.35 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.25 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77900-2022-1	98 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	08/28/2020
2	NDC: 77900-2022-2	237 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package	08/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/28/2020	12/31/2022

Labeler - Guangzhou Opseve Cosmetics Co., Ltd (421275457)

Registrant - Guangzhou Opseve Cosmetics Co., Ltd (421275457)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Opseve Cosmetics Co., Ltd		421275457	manufacture(77900-2022)

Revised: 3/2023

Document Id: f672ef12-bc2f-6d6c-e053-2995a90adb62

34390-5

Set id: adef3101-184c-09b9-e053-2995a90a28ca

Version: 3

Effective Time: 20230309