Antibacterial Hand Sanitizer by Shanghai Xiaoguo New Material Technology Co., Ltd

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Shanghai Xiaoguo New Material Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL HAND SANITIZER- dbdmh liquid 
Shanghai Xiaoguo New Material Technology Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Active Ingredient(s)

0.05% DBDMH

Purpose

Antiseptic, Hand Sanitizer

Use

Uses for hand washing to decrease the bacteria on the skin recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

Do not use in the eyes, in case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist 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

wet hands thoroughly with product

briskly rub hands together until dry

supervise children under 6 years in the use of this product

Other information

Keep in a cool place.

Inactive ingredients

stabilizer, medical grade purified water

Package Label - Principal Display Panel

ANTIBACTERIAL HAND SANITIZER 
dbdmh liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79277-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
1,3-DIBROMO-5,5-DIMETHYLHYDANTOIN (UNII: V9R5F9I7MZ) (1,3-DIBROMO-5,5-DIMETHYLHYDANTOIN - UNII:V9R5F9I7MZ)	1,3-DIBROMO-5,5-DIMETHYLHYDANTOIN	0.05 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79277-001-01	100 g in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020	01/07/2021
2	NDC: 79277-001-02	300 g in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2020	01/07/2021
3	NDC: 79277-001-03	500 g in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2020	01/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/30/2020	01/07/2021

Labeler - Shanghai Xiaoguo New Material Technology Co., Ltd (416844630)

Registrant - Shanghai Xiaoguo New Material Technology Co., Ltd (416844630)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Xiaoguo New Material Technology Co., Ltd		416844630	manufacture(79277-001)

Revised: 1/2021

Document Id: b846f1dd-760d-c881-e053-2a95a90ae6e7

34390-5

Set id: a94378ba-9acd-2e18-e053-2995a90a7c27

Version: 3

Effective Time: 20210106

 

Shanghai