KOSETTE SANITIZER WIPES- benzalkonium chloride liquid 
FIRSTCHAM 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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Drug Facts

ACTIVE INGREDIENT

Benzalkonium Chloride 0.1%

INACTIVE INGREDIENT

Water, Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Tocopheryl acetate, Citric acid

PURPOSE

Antiseptic

KEEP OUT OF REACH OF CHILDREN

■ If swallowed, get medical help or contact a Posion Control Center right away

Uses

■ Instant hand antiseptic to decrease bacteria on the skin

WARNINGS

Warnings


For external use only


Stop use and ask a doctor if
■ hypersensitivity symptoms such as erythema, itching and dermatitis happen
■ skin irritation happens


Do not use
■ in combination with soap or antibacterial cleansing agents
■ the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin


When using this product
■ avoid using repeatedly in the same area, skin irritation may occur
■ avoid getting into the eyes (if contact occurs, wash well with clean water)
■ if following abnormal symptoms persist, discontinue use: Irritation around the eyes, ears, mucous membranes, including the mouth, skin irritation, and rashes

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ Do not flush

Other information

■ Read the directions and warnings before use ■ Avoid freezing and excessive heat above 40 ℃ (104 ℉)

Package Label - kosette SANITIZER WIPES / 108g(20wipes)

Image of container

Package Label - kosette SANITIZER WIPES / 432g(80wipes)

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KOSETTE SANITIZER WIPES 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73923-0110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73923-0110-1108 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/2020
2NDC:73923-0110-2432 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - FIRSTCHAM CO., LTD (689905446)
Registrant - FIRSTCHAM CO., LTD (689905446)
Establishment
NameAddressID/FEIBusiness Operations
FIRSTCHAM CO., LTD689905446manufacture(73923-0110)

Revised: 5/2020
Document Id: a08ee1e2-6658-4679-a314-fe615fd6b662
Set id: 746b7dac-baef-47bd-812e-d6056f44d4f0
Version: 1
Effective Time: 20200519
 
FIRSTCHAM CO., LTD