53031-023 500ml Antibacterial Spray

ANTIBACTERIALSPRAY by

Drug Labeling and Warnings

ANTIBACTERIALSPRAY 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]

ANTIBACTERIALSPRAY- alcohol spray 
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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53031-023 500ml Antibacterial Spray

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: ANTIBACTERIAL

Purpose

ANTIBACTERIAL , Hand sterilization.

Efficacy:

Efficient to kill Staphylococcus aureus, Coliform bacteria, Pseudomonas aeruginosa and Candida albicans etc.

Use

Follow the standard method to use soap to wash hands, rinse with running water, dry with sterile towels, then direct spray this product on hands and forearms until moist, wait for 3 minutes, rub hand until dry.

Warnings

1.EXTREMELY FLAMMABLE.

pressurized container; protect from sunlight and don't expose to temperatures exceeding 50℃. Don't pierce or burn,even after use. Don't spray on a naked flame or any incandescent material. Keep it away from the reach of children. Don't spray towards eyes.

2. External application should not be taken orally and kept out of reach of children.

3. Use with caution if allergic to alcohol.

4. It should not be used to fat-soluble surfaces.

5. This product is irritating to wounds and mucous mem-branes.

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

• Follow the standard method to use soap to wash hands, rinse with running water, dry with sterile towels, then direct spray this product on hands and forearms until moist, wait for 3 minutes, rub hand until dry.

Other information

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

Inactive ingredients

purified water USP

Package Label - Principal Display Panel

500 ml in 1 bottle NDC: 53031-023-01

ANTIBACTERIALSPRAY 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53031-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	375 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53031-023-01	500 mL 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(53031-023)

Revised: 11/2020

Document Id: b4ca217c-f759-8a75-e053-2995a90ac514

34390-5

Set id: a924c929-e33d-7f44-e053-2a95a90a02f7

Version: 2

Effective Time: 20201123

 

Dongyang M