Hand Sanitizer Gel by Dongyang Medical & Hygienic Articles Co., Ltd. / Dongyang Medical & Hygienic Articles Co., Ltd. 53031-022 500ml 75%

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., 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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53031-022 500ml 75%

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

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

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin.

do not inhale or ingest.

Stop use and ask a doctor if irritation or redness develops.

condition persists for more than 72 hours.

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

• Do not store above 105F
• May discolor some fabrics.
• Harmful to wood finishes and plastics.

Inactive ingredients

AMINOMETHYLPROPANOL ,CARBOMER,GLYCERIN ,PROPYLENE GLYCOL, WATER

Package Label - Principal Display Panel

500 ml in 1 BOTTLE NDC: 53031-022-01

HAND SANITIZER GEL 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53031-022
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
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 980 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53031-022-01	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(53031-022)

Revised: 11/2020

Document Id: b4ca7f1a-e6ef-026d-e053-2a95a90af59c

34390-5

Set id: a8568326-d2b4-710f-e053-2995a90a8b37

Version: 3

Effective Time: 20201123

 

Dongyang M