ANTIBACTERIAL WET WIPES- benzalkonium chloride swab 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

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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ANTIBACTERIAL WET WIPES 40

Active ingredient

Benzalkonium chloride 0.1%...........Antiseptic 

Purpose

Antibacterial

Use

decreases bacteria on skin

Warnings

For external use only.

Keep out of reach of children

if swallowed

get medical help or contact a Poison Control Center right away.

Do not use 

if you are allergic to any of the ingredients.

When using this product

do not get into eyes.

If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

if irritation or rash

develops and continues for more than 72 hours

Keep out of reach of children.

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

Directions

For adults and children of 2 years and over use

on hands and face to clean and refresh, allow

skin to air dry.

For children under 2 years ask a doctor before use.

water, propylene glycol,

cocamidopropyl betaine, poly(hexamethyleneguanidine),PEG-7 glyceryl cocoate ,

hydrochloride, glycine, tetrasodium EDTA,  tocopheryl acetate, citric acid,

fragrance, methylchloroisothiazolinone, methylisothiazolinone,

PEG-40 hydrogenated castor oil.

wet wipes

ANTIBACTERIAL WET WIPES 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
2-METHYL-1,2-BENZOISOTHIAZOLIN-3-ONE (UNII: 81PV9X5Y68)  
PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76772-008-4040 in 1 PACKAGE; Type 0: Not a Combination Product05/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/07/2020
Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)

Revised: 5/2020
Document Id: a5164e4f-8888-2e69-e053-2995a90ad0f3
Set id: dcafea3f-0731-41ed-94dd-a1ca20f67a2b
Version: 2
Effective Time: 20200507
 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI