ELLE ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

ELLE ANTIBACTERIAL HAND WIPES by

Drug Labeling and Warnings

ELLE ANTIBACTERIAL HAND WIPES by is a Otc medication manufactured, distributed, or labeled by Alta Sales Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

INDICATIONS & USAGE

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ELLE ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79165-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79165-111-20	20 in 1 PACKET	08/25/2020
1		3.6 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 79165-111-80	80 in 1 PACKET	08/25/2020
2		3.6 g in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 79165-111-90	90 in 1 PACKET	08/25/2020
3		3.6 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/25/2020

Labeler - Alta Sales Inc (080087931)