Alcohol Wipes by NAISEN KELIN INDUSTRY CO., LTD Naisen Kelin 004-02

Alcohol Wipes by

Drug Labeling and Warnings

Alcohol 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]

ALCOHOL 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.

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Naisen Kelin 004-02

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

For external use only. Flammable. Keep away from heat or flame

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

Front and Back Labels10 Wipes NDC: 81098-004-02

ALCOHOL WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81098-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
Inactive Ingredients
Ingredient NameStrength
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81098-004-0210 in 1 PACKET; Type 0: Not a Combination Product12/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/21/202012/15/2021
Labeler - NAISEN KELIN INDUSTRY CO., LTD (658457965)
Establishment
NameAddressID/FEIBusiness Operations
NAISEN KELIN INDUSTRY CO., LTD658457965manufacture(81098-004)

Revised: 2/2022
Document Id: d79fbe47-1397-632c-e053-2a95a90aa93e
Set id: b7057694-3ba5-d405-e053-2995a90a7c77
Version: 3
Effective Time: 20220209