Hand Sanitizer by Guangzhou Opseve Cosmetics Co., Ltd HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient(s)

Alcohol 68% 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

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

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

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

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
  

Inactive ingredients

carbomer, glycerin, sterile distilled water, triethanolamine.

Package Label - Principal Display Panel

500 mL NDC: 77900-2020-1

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77900-2020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	340 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)	1.15 mL  in 500 mL
GLYCERIN (UNII: PDC6A3C0OX)	5 mL  in 500 mL
CARBOMER 980 (UNII: 4Q93RCW27E)	1.8 mL  in 500 mL
WATER (UNII: 059QF0KO0R)	152.05 mL  in 500 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77900-2020-1	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/20/2020

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(77900-2020)