SUDS HAND SANITIZER- benzealkonium 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:
Pro Chem, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For hand-washing to decrease bacteria on the skin, only when water is not available Antiseptic irritation and redness develop
Authorization status:
OTC monograph not final
Authorization number:
63830-457-10, 63830-457-12, 63830-457-14, 63830-457-17, 63830-457-18

SUDS HAND SANITIZER- benzealkonium chloride liquid

Pro Chem, 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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SUDS Hand Sanitizer Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

benzalkonium chloride USP 0.13%

Drug Facts Box OTC-Indications & Usage Section

For hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box-OTC When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box-OTC Stop Use Section

irritation and redness develop

Drug Facts Box-OTC Keep Out Of Reach Of Children Section

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

Drug Facts Box-OTC Dosage & Administration Section

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your

hand

rub hands together until dry

wash hands with soap and water at earliest opportunity

Drug Facts Box-OTC Inactive Ingredient Section

water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate,

methylchloroisothiazolinone, methylisothiazolinone, fragrance

SUDS Hand Sanitizer

SUDS Hand Sanitizer

SUDS HAND SANITIZER

benzealkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 30 -457

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

1.3 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 38 30 -457-

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

0 8 /12/20 19

2

NDC:6 38 30 -457-

50 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /12/20 19

3

NDC:6 38 30 -457-

378 5 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /12/20 19

Pro Chem, Inc.

4

NDC:6 38 30 -457-

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

0 8 /12/20 19

5

NDC:6 38 30 -457-

532 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /12/20 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 8 /12/20 19

Labeler -

Pro Chem, Inc. (061396065)

Registrant -

ABC Compounding Co., Inc. (003284353)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ABC Co mpo unding Co ., Inc.

0 0 328 4353

ma nufa c ture (6 38 30 -457)

Revised: 8/2019

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