53031-025 4L HAND SANITIZER GEL DONGYANG MEDICAL

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Dongyang Medical & Hygienic Articles Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL- hand sanitizer gel gel 
Dongyang Medical & Hygienic Articles 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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53031-025 4L HAND SANITIZER GEL DONGYANG MEDICAL

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

• 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

POLYACRYLIC ACID , AMINOMETHYLPROPANOL ,PROPYLENE GLYCOL,GLYCERIN , WATER

Package Label - Principal Display Panel

4 L NDC: 53031-025-01

HAND SANITIZER GEL 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53031-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	3000 mL  in 4 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53031-025-01	4 L in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	11/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	11/23/2020

Labeler - Dongyang Medical & Hygienic Articles Co., Ltd. (530310429)

Registrant - Dongyang Medical & Hygienic Articles Co., Ltd. (530310429)

Establishment
Name	Address	ID/FEI	Business Operations
Dongyang Medical & Hygienic Articles Co., Ltd.		530310429	manufacture(53031-025)

Revised: 11/2020

Document Id: b4c99954-2548-1486-e053-2995a90a917c

34390-5

Set id: a96ee530-5483-d967-e053-2995a90ae9e2

Version: 2

Effective Time: 20201123

 

Dongyang M