Sanitizing Wipe by NAISEN KELIN INDUSTRY CO., LTD Naisen Kelin 001-01

Sanitizing Wipe by

Drug Labeling and Warnings

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

Drug Details [pdf]

SANITIZING WIPE- alcohol cloth 
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 001-01

Active Ingredient(s)

Ethyl Alcohol 75% (alc/vol). Purpose: Antiseptic

Purpose

Antiseptic

Use

Sanitizing wipes to help reduce bacteria on the skin or surface of object.

Not to be used on therapeutic devices and hospital.

Warnings

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

Do not use in contact with 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.

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

Keep out of reach of children unless under adult supervision.

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

Directions

Discard after a single use and do not flush in the toilet.

Other information

Store in a cool dry place below 30˚C

Inactive ingredients

Water, Benzalkonium Chloride, Polyaminopropyl Biguanide, Citric Acid

Package Label - Principal Display Panel

1 wipe NDC: 81098-001-01

SANITIZING WIPE 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81098-001
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

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81098-001-01	1 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(81098-001)

Revised: 2/2022

Document Id: d79fd756-203f-3bb2-e053-2995a90a1768

34390-5

Set id: b6ed6a16-47d5-43ac-e053-2a95a90a10dc

Version: 3

Effective Time: 20220209