SANIWASH ANTIMICROBIAL- chloroxylenol liquid

Saniwash Antimicrobial by

Drug Labeling and Warnings

Saniwash Antimicrobial by is a Otc medication manufactured, distributed, or labeled by Safetec of America, Inc., Safetec of America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Chloroxylenol (PCMX) 0.6%

Purpose

Antiseptic

Uses

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

Warnings

For external use only

When using this product

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

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

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

Directions

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

Inactive ingredients

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

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 - 800 mL Bag-In-Box

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 - 16 oz. BOTTLE

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

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

INGREDIENTS AND APPEARANCE

SANIWASH ANTIMICROBIAL 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-1122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q)	Chloroxylenol	0.0060 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Methylparaben (UNII: A2I8C7HI9T)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Water (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-1122-6	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/22/2014
2	NDC: 61010-1122-4	800 mL in 1 BAG; Type 0: Not a Combination Product	04/22/2014	04/12/2017
3	NDC: 61010-1122-3	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/22/2014
4	NDC: 61010-1122-7	208198 mL in 1 DRUM; Type 0: Not a Combination Product	04/22/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2014

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc		874965262	MANUFACTURE(61010-1122)