53031-508 DISINFECTANT SPRAY 20200925

DISINFECTANTSPRAY by

Drug Labeling and Warnings

DISINFECTANTSPRAY 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]

DISINFECTANTSPRAY- 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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53031-508 DISINFECTANT SPRAY 20200925

Active Ingredient(s)

Alcohol 75% v/v. Purpose: DISINFECTANT

Purpose

DISINFECTANT

Use

Hold container upright 6"-12" from surface. To clean surface, spray for 3-4 seconds until covered with mist, allow to air dry for 10 minutes. For surfaces working with food, spray for 3-4 seconds until covered with mist, allow to air dry for 10 minutes, then rinse thoroughly.

Warnings

• Causes eye irritation. Do not spray on eyes, on skin, or on clothing.
• Keep away from heat, sparks, and flames. Do not puncture container. Exposure to temperature above 130℉ may cause bursting.
• KEEP AWAY FROM CHILDREN.

Do not use

• On polished wood, leather, rayon fabric, or acrylic plastics.

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.

FIRST AID: If in eyes, hold eyes open and rinse eye slowly and gently with water for 15-20 minutes. If irritation continues, call a poison control center or doctor for advice.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Hold container upright 6"-12" from surface. To clean surface, spray for 3-4 seconds until covered with mist, allow to air dry for 10 minutes. For surfaces working with food, spray for 3-4 seconds until covered with mist, allow to air dry for 10 minutes, then rinse thoroughly.

Other information

• Exposure to temperature above 130℉ may cause bursting.

Inactive ingredients

Water, Fragrance.

Package Label - Principal Display Panel

500 mL NDC: 53031-508-01

DISINFECTANTSPRAY 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53031-508
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
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53031-508-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2020	11/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/08/2020	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(53031-508)

Revised: 11/2020

Document Id: b4c89635-5e89-dd70-e053-2a95a90a3819

34390-5

Set id: b020aaac-ce88-2ac7-e053-2995a90a1548

Version: 2

Effective Time: 20201123

 

Dongyang M