Saniwash Antimicrobial

Manufacturer: Safetec of America, Inc. | Safetec of America, Inc
Effective date: 2024-02-05
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:08:32

Label at a glance#

ProductSaniwash Antimicrobial

Active ingredientCHLOROXYLENOL

Label structure11 sections

Indications and uses

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.

Contacts and useful links#

PhoneLabel contact1-800-456-7077

Websitewww.safetec.com

www.safetec.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol (PCMX) 0.6%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

supervise children under 6
do not use in the eyes. If contact occurs, rinse thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor ifirritation or redness develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, cocamide DEA, cocamidopropyl betaine, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

PRINCIPAL DISPLAY PANEL - 1 GALLON BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-1122-6

Safetec

SaniWash

Antimicrobial Hand Soap

Effective against germs

Cleans dirty hands yet gentle on skin

Mild pleasant fragrance with Aloe

Reorder No. 34455

NET CONTENTS

1 gal (3.785 L)

PRINCIPAL DISPLAY PANEL - 1 GALLON BOTTLE

PRINCIPAL DISPLAY PANEL - 800 mL Bag-In-Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured by
Safetec

Safetec of America, Inc.

Buffalo, NY 14215

1-800-456-7077 www.safetec.com

Reorder No. 34465

NDC 61010-1122-4

27.05 fl. oz. (800 ml.)

SaniWash

Antimicrobial Hand Soap

PRINCIPAL DISPLAY PANEL - 800 mL Bag-In-Box

PRINCIPAL DISPLAY PANEL - 16 oz. BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-1122-3

SaniWash

Antimicrobial Hand Soap

Effective against germs

Cleans dirty hands yet gentle on skin

Mild pleasant fragrance with Aloe

NET CONTENTS

16 fl. oz. (473 ml)

Safetec

Reorder No. 34452

Principal Display Panel - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-1122-7

Safetec

SaniWash^®

Antimicrobial Hand Soap

Effective against germs

Cleans dirty hands yet gentle on skin

Mild pleasant fragrance with Aloe

NET CONTENTS

55 gal (208.2 L)

Reorder No. 34457

Manufactured by SAFETEC OF AMERICA, Inc.Buffalo, NY 14215 800-456-7077 www.safetec.com

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-1122-3	2024-02-13	C162847	48780-1	1030e365-21d2-111a-e063-dadaa90a10e2	61010-1122, Saniwash
61010-1122-4	2024-02-13	C162847	48780-1	1030e365-21d2-111a-e063-dadaa90a10e2	61010-1122, Saniwash
61010-1122-6	2024-02-13	C162847	48780-1	1030e365-21d2-111a-e063-dadaa90a10e2	61010-1122, Saniwash
61010-1122-7	2024-02-13	C162847	48780-1	1030e365-21d2-111a-e063-dadaa90a10e2	61010-1122, Saniwash
61010-1122-3	2024-01-30	C162847	48780-1	1030e365-21d2-111a-e063-dadaa90a10e2	61010-1122, Saniwash
61010-1122-4	2024-01-30	C162847	48780-1	1030e365-21d2-111a-e063-dadaa90a10e2	61010-1122, Saniwash
61010-1122-6	2024-01-30	C162847	48780-1	1030e365-21d2-111a-e063-dadaa90a10e2	61010-1122, Saniwash
61010-1122-7	2024-01-30	C162847	48780-1	1030e365-21d2-111a-e063-dadaa90a10e2	61010-1122, Saniwash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61010-1122-3	Saniwash Antimicrobial	473 mL in 1 BOTTLE, PUMP	LIQUID	473	4
61010-1122-4	Saniwash Antimicrobial	800 mL in 1 BAG	LIQUID	800	4
61010-1122-6	Saniwash Antimicrobial	3785 mL in 1 BOTTLE, PUMP	LIQUID	3785	4
61010-1122-7	Saniwash Antimicrobial	208198 mL in 1 DRUM	LIQUID	208198	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-1122	SANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]	4	Current NDC, Legacy NDC, 4 package rows	20240214_6ac9df02-225d-4115-a9c6-a492faafe68a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Chloroxylenol	ACTIVE INGREDIENT	0F32U78V2Q	2
Chloroxylenol	ACTIVE MOIETY	0F32U78V2Q	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	2
Cocamidopropyl Betaine	INACTIVE INGREDIENT	5OCF3O11KX	2
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	2
Diazolidinyl Urea	INACTIVE INGREDIENT	H5RIZ3MPW4	2
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	2
SODIUM LAURETH-3 SULFATE	INACTIVE INGREDIENT	BPV390UAP0	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Saniwash Antimicrobial
Chloroxylenol
ALOE VERA LEAF
SODIUM LAURETH-3 SULFATE
COCO DIETHANOLAMIDE
COCAMIDOPROPYL BETAINE
PROPYLENE GLYCOL
PROPYLPARABEN
METHYLPARABEN
DIAZOLIDINYL UREA
WATER
SODIUM CHLORIDE
EDETATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61010-1122	61010-1122-6, 61010-1122-4, 61010-1122-3, 61010-1122-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
SODIUM LAURETH-3 SULFATE	BPV390UAP0	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
EDETATE SODIUM	MP1J8420LU	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
CHLOROXYLENOL	0F32U78V2Q	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 365 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii+route 115 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii+dosage form 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route 75 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOAP / TOPICAL	0.12 %w/w		Exact identifier — unii+route 25 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route 115 equally ranked IID candidates
Diazolidinyl Urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
Diazolidinyl Urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 15 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route 115 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 115 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii+route 115 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii+route 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii+route 75 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii+route 25 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii+route 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 75 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii+route 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+dosage form 115 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii+route 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route 115 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii+route 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route 115 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii+route 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii+route 115 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii+route 75 equally ranked IID candidates
SODIUM LAURETH-3 SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SPRAY / TOPICAL	0.1 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii+route 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii+route 115 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	SHAMPOO / TOPICAL		600 mg	Exact identifier — unii+route 25 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii+route 115 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii+route 115 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii+route 25 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii+route 115 equally ranked IID candidates
Diazolidinyl Urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii+route 115 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii+route 75 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii+route 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii+route 75 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii+route 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii+route 115 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+dosage form 115 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOAP / TOPICAL	0.12 %w/w		Exact identifier — unii+route 25 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii+route 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii+route 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii+route 115 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii+route 25 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii+dosage form 75 equally ranked IID candidates
Diazolidinyl Urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 15 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii+route 115 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii+route 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii+route 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route 115 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii+route 115 equally ranked IID candidates
COCO DIETHANOLAMIDE	COCO DIETHANOLAMIDE	92005F972D	CREAM / TOPICAL		30 mg	Exact identifier — unii+route 25 equally ranked IID candidates
SODIUM LAURETH-3 SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CREAM / TOPICAL	NA		Exact identifier — unii+route 15 equally ranked IID candidates
SODIUM LAURETH-3 SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CREAM / TOPICAL	NA		Exact identifier — unii+route 15 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Saniwash Antimicrobial	CHLOROXYLENOL	Safetec of America, Inc.	6ac9df02-225d-4115-a9c6-a492faafe68a	2024-02-05	Warnings	Exact identifier ndc (package): 61010-1122-3 ndc (package): 61010-1122-6 ndc (package): 61010-1122-4 ndc (package): 61010-1122-7 ndc (product): 61010-1122 ndc11 (package): 61010112203 ndc11 (package): 61010112206 ndc11 (package): 61010112204 ndc11 (package): 61010112207 spl id: 10a74b7b-a6c3-f224-e063-6294a90a4f67 spl set id: 6ac9df02-225d-4115-a9c6-a492faafe68a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.