OP Biotech Karat second submittal 005-06

KARAT Instant Hand Sanitizer by

Drug Labeling and Warnings

KARAT Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by OP Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KARAT INSTANT HAND SANITIZER- alcohol gel 
OP Biotech 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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OP Biotech Karat second submittal 005-06

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

For cleaning your hands to decrease bacteria on the skin that can potentially cause disease.

Warnings

Do not freeze, for external use only.

Highly flammable.

Keep away for fire and flames.

Do not use in ears or mouth. Highly flammable.

Avoid contact with eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if redness or irritation develops and persist for more than 72 hours.

Keep out of reach of children. Get medical help immediately if swallowed.

Directions

• Apply an appropriate amount of Hand Gel into palms and spread on both hands. Rub into skin until dry.

Other information

Store in a cool and dry place. Avoid high temperature, humidity, and direct sunlight.

Expiration date 3 Years

Inactive ingredients

Water, Carbomer, Aminomethyl propanol, Orange Oil

Package Label - Principal Display Panel

500 mL NDC: 75798-005-06

KARAT INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75798-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ORANGE OIL (UNII: AKN3KSD11B)
WATER (UNII: 059QF0KO0R)
CARBOMER 1342 (UNII: 809Y72KV36)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75798-005-06	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/08/2020	05/05/2021

Labeler - OP Biotech Co., Ltd. (658280709)

Establishment
Name	Address	ID/FEI	Business Operations
OP Biotech Co., Ltd.		658280709	manufacture(75798-005)

Revised: 5/2021

Document Id: c19c8a93-80d8-2227-e053-2a95a90a6331

34390-5

Set id: a79bb36a-c86b-48b4-e053-2a95a90a1118

Version: 2

Effective Time: 20210505