AERISGUARD ACTISAN HAND SANITIZER- benzalkonium chloride solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Aeris Environmental LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic For hand sanitizing to decrease bacteria on the skin
Authorization status:
OTC monograph not final
Authorization number:
81124-001-01, 81124-001-02, 81124-001-03, 81124-001-04, 81124-001-05, 81124-001-06, 81124-001-07, 81124-001-08, 81124-001-09, 81124-001-10

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AERISGUARD ACTISAN HAND SANITIZER- benzalkonium chloride solution

Aeris Environmental LLC

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.

----------

Active Ingredients

Benzalkonium chloride 0.13%

Purpos e

Antiseptic

Us es

For hand sanitizing to decrease bacteria on the skin

WARNINGS

For External use only

When using this product avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or redness develops

condition persists 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

Apply enough product to cover hands

Rub together until dry without wiping

Other Information

Store at room temperature

Inactive Ingredients

water, cocamidopropyl betaine, PEG-7 glyceryl cocoate, propylene glycol, tetrasodium edta,

phenoxyethanol, sodium benzoate, lactic acid

sensitive

skin

0% Alcohol

aeris

guard

ACTISAN

Hand Sanitizer

Complies with EN-13727-Bactericidal test

For sensitive skin Leaves soft skin feel

Contains moisturizer and emollient Mild and skin compatible

Non-tacky

Active moisturizer

Fragrance free and pH balanced

ALCOHOL

FREE

NET CONTENTS

3.5 fl. oz. (103mL)

AERISGUARD ACTISAN HAND SANITIZER

benzalkonium chloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 1124-0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

LACTIC ACID (UNII: 33X0 4XA5AT)

PEG-7 GLYCERYL CO CO ATE (UNII: VNX7251543)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

WATER (UNII: 0 59 QF0 KO0 R)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:8 1124-0 0 1-0 1 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/24/20 20

2

NDC:8 1124-0 0 1-

10 3.5 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/24/20 20

3

NDC:8 1124-0 0 1-

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/24/20 20

4

NDC:8 1124-0 0 1-

236 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/24/20 20

5

NDC:8 1124-0 0 1-

473 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/24/20 20

6

NDC:8 1124-0 0 1-

9 46 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/24/20 20

7

NDC:8 1124-0 0 1-

38 0 0 mL in 1 PAIL; Type 0 : No t a Co mbinatio n Pro duct

11/24/20 20

8

NDC:8 1124-0 0 1-

19 0 0 0 mL in 1 PAIL; Type 0 : No t a Co mbinatio n Pro duct

11/24/20 20

9

NDC:8 1124-0 0 1-

20 9 0 0 0 mL in 1 DRUM; Type 0 : No t a Co mbinatio n

Pro duc t

11/24/20 20

10

NDC:8 1124-0 0 1-10

10 450 0 0 mL in 1 TANK; Type 0 : No t a Co mbinatio n

Pro duc t

11/24/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

11/24/20 20

Aeris Environmental LLC

Labeler -

Aeris Environmental LLC (117533699)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ChemQuest Chemicals LLC

8 350 520 51

ma nufa c ture (8 1124-0 0 1)

Revised: 11/2020

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