Instant Hand Sanitizer by NAISEN KELIN INDUSTRY CO., LTD Naisen Kelin 003-01

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by NAISEN KELIN INDUSTRY CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INSTANT HAND SANITIZER- alcohol gel 
NAISEN KELIN INDUSTRY 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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Naisen Kelin 003-01

Active Ingredient(s)

Ethyl Alcohol 75%. Purpose: Antiseptic

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

Flammable, keep away from heat, spark, electrical fire or flame.

For external use only. Do not put into mouth and do not touch eyes.

For external use only. Do not put into mouth and do not touch eyes.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a physician.

Ask a doctor before use if you have deep or puncture wounds, animal bites, serious burns.

Keep out of reach of children unless under adult supervision. Not recommended for infants.

If swallowed, get medical help or contact a Poison Control Center immediately.

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 and allow surface to air dry.

Other information

Store in a cool dry place below 30˚C

Inactive ingredients

Water, Propylene Glycol, Carbomer, Triethanolamine, o-Cymen-5-ol

Package Label - Principal Display Panel

2 mL NDC: 81098-003-01

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81098-003
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 1342 (UNII: 809Y72KV36)
TROLAMINE (UNII: 9O3K93S3TK)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81098-003-01	2 mL in 1 PACKET; Type 0: Not a Combination Product	12/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/20/2020	12/15/2021

Labeler - NAISEN KELIN INDUSTRY CO., LTD (658457965)

Establishment
Name	Address	ID/FEI	Business Operations
NAISEN KELIN INDUSTRY CO., LTD		658457965	manufacture(81098-003)

Revised: 2/2022

Document Id: d7a02f3b-aa8f-23b2-e053-2995a90a338a

34390-5

Set id: b6f1f97f-52c1-704e-e053-2a95a90a174f

Version: 6

Effective Time: 20220209