SMART SAN ALCOHOL-FREE HAND SANITIZER FOAM- benzalkonium chloride liquid

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Best Sanitizers, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antiseptic Uses - sanitize hands to help reduce bacteria that potentially can cause disease - helps to prevent cross-contamination - recommended for repeated use - helps prevent drying of skin
Authorization status:
OTC monograph not final
Authorization number:
59900-119-05, 59900-119-08, 59900-119-10

SMART SAN ALCOHOL-FREE HAND SANITIZER FOAM- benzalkonium chloride liquid

Best Sanitizers, 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.

----------

Drug Facts

Active ingredient

Benzalkonium Chloride 0.12% w/w

Purpos e

Antiseptic

Us es

sanitize hands to help reduce bacteria that potentially can cause disease

helps to prevent cross-contamination

recommended for repeated use

helps prevent drying of skin

Warnings

For external use only

When using this product

do not use in or near eyes

use in a well-ventilated area

for external use only

Stop use and ask a doctor if irritation or redness develop.

Keep out of reach of children.

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

Directions

receive a small amount of foam into palm of hand

rub thoroughly over all surfaces of both hands

rub hands together until dry

Other information

store in a cool, dry place below 104 F (40

Inactive ingredients

Water, cocamidopropyl betaine, glycerin, poloxamer 124, phenoxyethanol, benzyl alcohol,

dehydroacetic acid, sodium hydroxide, citric acid

Ques tions ?

Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am - 4 pm PST

versaclenz compatible

Smart San

alcohol-free

hand sanitizer

foam

with natural

emollients to

soften hands

kills 99.9%-99.999%

of tested pathogens

Net Contents:

SMART SAN ALCOHOL-FREE HAND SANITIZER FOAM

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 9 0 0 -119

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

1.2 mg

in 1 mL

Inactive Ingredients

Best Sanitizers, Inc.

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LO XAMER 12 4 (UNII: 1S6 6 E28 KXA)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

DEHYDRO ACETIC ACID (UNII: 2KAG279 R6 R)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:59 9 0 0 -119 -0 5

1250 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/10 /20 19

2

NDC:59 9 0 0 -119 -0 8

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

0 5/10 /20 19

3

NDC:59 9 0 0 -119 -10

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

0 5/10 /20 19

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 rt333E

0 5/10 /20 19

Labeler -

Best Sanitizers, Inc. (957473614)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Best Sanitizers, Inc.

6 27278 224

ma nufa c ture (59 9 0 0 -119 )

Revised: 5/2019

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