QS PLUS HAND SANITIZING WIPES - benzethonium chloride cloth

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

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Prekės savybės Prekės savybės (SPC)

16-03-2010

Veiklioji medžiaga:
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)
Prieinama:
ABC Compounding Co., Inc.
INN (Tarptautinis Pavadinimas):
BENZETHONIUM CHLORIDE
Sudėtis:
BENZETHONIUM CHLORIDE 2 mg in 1 g
Vartojimo būdas:
TOPICAL
Recepto tipas:
OTC DRUG
Terapinės indikacijos:
For hand-washing to decrease bacteria on the skin, only when water is not available Antiseptic irritation and redness develop
Autorizacija statusas:
OTC monograph not final
Registracijos numeris:
62257-785-23, 62257-785-29

QS PLUS HAND SANITIZING WIPES - benzethonium chloride cloth

ABC Compounding Co., 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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QS Plus Hand Sanitizing Wipes 7805 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

benzethonium chloride USP 0.2%

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

wet hands thoroughly with product and allow to air dry without wiping

wash hands with soap and water at earliest opportunity

Drug Facts Box-OTC Inactive Ingredient Section

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

QS Plus Hand Sanitizing Wipes 7805 50 pre-saturated wipes

780550PA.jpg QS Plus Hand Sanitizing Wipes 50 pre-moistened wipes

QS PLUS HAND SANITIZING WIPES

benzethonium chloride cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 2257-78 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -

UNII:1VU15B70 BP)

BENZETHONIUM CHLORIDE 2 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 2257-78 5-23

30 2 g in 1 CANISTER

2

NDC:6 2257-78 5-29

6 17 g in 1 CANISTER

ABC Compounding Co., Inc.

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 rt333

0 4/0 9 /20 0 9

Labeler -

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

Revised: 3/2010

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