SANTI WASH ANTISEPTIC HAND WASH- pividone iodine liquid

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

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Active ingredient:
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Available from:
ABC Compounding Co., 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:
62257-275-14, 62257-275-55

SANTI WASH ANTISEPTIC HAND WASH- pividone iodine liquid

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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Santi Wash Antiseptic Hand Wash Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Povidone-Iodine, 5.0% (equivalent to 0.5% available iodine)

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 and forearms

apply 5 milliliters (teaspoonful) or palmful to hands and forearms

scrub thoroughly for 1 minute and rinse

Drug Facts Box-OTC Inactive Ingredient Section

water, sodium lauryl sulfate, glycerin, hydroxyethyl cellulose, sodium phosphate dibasic anhydrous

Santi Wash Antiseptic Hand Wash

Santi Wash Antiseptic Hand Wash Label

SANTI WASH ANTISEPTIC HAND WASH

pividone iodine liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 2257-275

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRO XYETHYL CELLULO SE ( 150 0 MPA.S AT 1%) (UNII: L6 0 5B58 9 2V)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: 22ADO53M6 F)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 2257-275-

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

Pro duc t

11/0 6 /20 18

2

NDC:6 2257-275-

20 8 20 mL in 1 DRUM; Type 0 : No t a Co mbinatio n Pro duct

11/0 6 /20 18

Marketing Information

ABC Compounding Co., Inc.

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

11/0 6 /20 18

Labeler -

ABC Compounding Co., Inc. (003284353)

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 2257-275)

Revised: 4/2019

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