Antiseptic Wipes by NAISEN KELIN INDUSTRY CO., LTD Naisen Kelin, 002-02

Antiseptic Wipes by

Drug Labeling and Warnings

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

Drug Details [pdf]

ANTISEPTIC WIPES- 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.

----------

Naisen Kelin, 002-02

Active Ingredient(s)

Benzalkonium Chloride 0.1%. 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

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

For external use only. Do not put in 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.

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

Do not apply internally. Store in a cool dry place below 30˚C

Inactive ingredients

Water, Sodium Benzoate, Phenoxyethanol, Polyaminopropyl Biguanide, PEG-40, Hydrogenated Castor Oil, Citric Acid

Package Label - Principal Display Panel

100 Wipes NDC: 81098-002-02

ANTISEPTIC WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81098-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81098-002-02	100 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(81098-002)

Revised: 2/2022

Document Id: d7a02f11-0599-a76f-e053-2995a90ad5bd

34390-5

Set id: b6f03e31-6b8b-772b-e053-2a95a90a3089

Version: 10

Effective Time: 20220209