DISPOSABLE DISINFECTANT GEL- alcohol gel

Disposable Disinfectant Gel by

Drug Labeling and Warnings

Disposable Disinfectant Gel by is a Otc medication manufactured, distributed, or labeled by Zhengzhou Airport Kangyue Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Disposable Disinfectant Gel

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Disposable Disinfectant Gel

Use

Disposable Disinfectant Gel 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

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

Inactive ingredients

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
WATER
"ALPHA.-TOCOPHEROL ACETATE, DL"
GLYCERIN
TROLAMINE
ALOE

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

DISPOSABLE DISINFECTANT GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78051-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78051-101-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78051-101-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78051-101-03	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 78051-101-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 78051-101-05	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Zhengzhou Airport Kangyue Biotechnology Co., Ltd. (409875170)

Establishment
Name	Address	ID/FEI	Business Operations
Zhengzhou Airport Kangyue Biotechnology Co., Ltd.		409875170	manufacture(78051-101)