Disposable Hand Antibacterial Gel

Disposable Hand Antibacterial Gel by

Drug Labeling and Warnings

Disposable Hand Antibacterial Gel by is a Otc medication manufactured, distributed, or labeled by Biocaro Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DISPOSABLE HAND ANTIBACTERIAL GEL- disposable hand antibacterial gel gel 
Biocaro Pharmaceutical 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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Disposable Hand Antibacterial Gel

Active Ingredient(s)

POLYHEXAMETHYLENE GUANIDINE 0.4% v/v. Purpose: Disinfection

Purpose

Disinfection

Use

Use: Suitable for sanitary hand disinfectionand surgical hand disinfection.

Warnings

Warning:1. This product is a disinfectant for externaluse and cannot be taken orally;

2. Keep it out of reach of children

Do not use

• 1. This product is a disinfectant for external use and cannot be taken orally;2. Keep it out of reach of children

/

/

Keep out of reach of children.

Directions

• Direction:1. Sanitize your hands: Take 3ml of this productand apply it to your hands, rub it for 1 minute.2. Disinfection of surgical hands: Wash and drythe hands, forearms, and lower third of theupper arm with soap or antibacterial handsanitizer according to the specificationsTake 5-10ml of this product and apply it evenon the hands, forearm and lower third of theupper arm. Rub the skin to dryness and leaveit on for 3 minutes

Other information

Storage:sealed, protected from light, stored in a cool and dry place

Inactive ingredients

Inactive ingredient: Water, Glycerin, HPC Mint Flavor

Package Label - Principal Display Panel

DISPOSABLE HAND ANTIBACTERIAL GEL 
disposable hand antibacterial gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78872-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF)	POLIHEXANIDE	0.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MINT (UNII: FV98Z8GITP)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROGESTERONE CAPROATE (UNII: 276F2O42F5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78872-005-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2020	03/01/2021

Labeler - Biocaro Pharmaceutical Co., Ltd (527295318)

Establishment
Name	Address	ID/FEI	Business Operations
Biocaro Pharmaceutical Co., Ltd		527295318	manufacture(78872-005)

Revised: 4/2021

Document Id: c0d920b0-e9ec-5ee4-e053-2995a90af65f

34390-5

Set id: a829f10f-b28b-0e62-e053-2995a90a0646

Version: 4

Effective Time: 20210426