75% Alcohol Rinse-free antibacterial gel

75% Alcohol Rinse-free antibacterial gel by

Drug Labeling and Warnings

75% Alcohol Rinse-free 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]

75% ALCOHOL RINSE-FREE ANTIBACTERIAL GEL- 75% alcohol rinse-free antibacterial gel gel 
Biocaro Pharmaceutical 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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75% Alcohol Rinse-free antibacterial gel

Active Ingredient(s)

Ethanol 75% v/v. Purpose: Antiseptic

Purpose

disinfection , Hand Sanitizer

Use

Suitable For Cleaning AndDisinfecting Your Hand To AvoidMicroorganisms Breed, Such AsEscherichia Coli, Staphylococcus AureusCandida Albicans

Warnings

Warning For External Use, Oral Administration Is Prohibited: Those Who Are Allergic To Ethanol Are Prohibited Stay Away From Fire Sources: Keep Out of Reach Of Children

Do not use

• Those who are allergic to ethanol are prohibited, stay away from fire soureces

use Suitable For Cleaning AndDisinfecting Your Hand To AvoidMicroorganisms Breed, Such As Escherichia Coli, Staphylococcus Aureus Candida Albicans

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.

Directions

Apply Appropriate This Gel On Your Hand, And Rub Without Washing.

Other information

Sealed, protected from lightstored in a cool and dry placeI Shelf lifel 12 months

Inactive ingredients

water, carbopol , glycerol, triethanoiamine, essence

Package Label - Principal Display Panel

75% ALCOHOL RINSE-FREE ANTIBACTERIAL GEL 
75% alcohol rinse-free antibacterial gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78872-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78872-001-01	100 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
OTC monograph not final	part333A	03/30/2020	01/01/2021

Labeler - Biocaro Pharmaceutical Co., Ltd (527295318)

Establishment
Name	Address	ID/FEI	Business Operations
Biocaro Pharmaceutical Co., Ltd		527295318	manufacture(78872-001)

Revised: 4/2021

Document Id: c0d8b2be-481a-67d4-e053-2995a90af3da

34390-5

Set id: a83efd20-a20e-26f7-e053-2a95a90ab145

Version: 2

Effective Time: 20210426