ELLE ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth 
Alta Sales Inc

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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ELLE ANTIBACTERIAL HAND WIPES

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use • Decreases bacteria on skin

Warnings

For external use only

Keep out of eyes. In case of eye contact, rinse with water.

If irritation develops, discontinue use.

Consult a doctor if irritation persists more than 72 hours.

If swallowed, seek medical attention or contact a Poison Control Center.

Keep out of the children, except with adult supervision.

Directions for use

Thoroughly wipe hands and face as desired.

Allow to dry without wiping.

Discard wipe in trash receptacle after use. Do not flush.

Inactive ingredients

Aqua, Phenoxyethanol, Perfume, Propylene Glycol, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Benzoic acid, Tetrasodium Edta, Dehydroacetic acid, Glycerin, Polysorbate 20, Citric acid

KILLS 99.99% OF GERMS

HYPOALLERGENIC • PARABEN FREE

DERMATOLOGICALLY TESTED

ELLE™

is used by Alta Sales Inc under license

from HACHETTE FILIPACCHI PRESSE

SA, Paris, France.

Made in Turkey

www.ellepersonalcare.us

Packaging

IMAGEIMAGE

ELLE ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79165-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79165-111-2020 in 1 PACKET08/25/2020
13.6 g in 1 PACKAGE; Type 0: Not a Combination Product
2NDC:79165-111-8080 in 1 PACKET08/25/2020
23.6 g in 1 PACKAGE; Type 0: Not a Combination Product
3NDC:79165-111-9090 in 1 PACKET08/25/2020
33.6 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/25/2020
Labeler - Alta Sales Inc (080087931)

Revised: 8/2020
Document Id: dcfa103e-80cd-4539-9650-002f3e858c52
Set id: fc09f27d-7549-4111-ae2d-0657b229653a
Version: 1
Effective Time: 20200827
 
Alta Sales Inc