ANTIMICROBIAL HAND WASH- chloroxylenol soap

Antimicrobial Hand Wash by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Chloroxylenol (PCMX) 0.6%

Purpose

Antiseptic

Uses

• for handwashing to decrease bacteria on skin. Recommended for repeated use.

Warnings

For external use only.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask doctor if

• irritation and redness develops and persists 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
• supervise children under 6 years of age

Inactive Ingredients

aloe vera, cocamide DEA, cocamidopropyl betaine, D&C Red #33, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA

Made in U.S.A.

PRINCIPAL DISPLAY PANEL – 800 mL Box

Henry Schein

112-5987

Maxiclens

Antimicrobial Hand Wash

NDC: 0404-5987-01

27.05 FL. OZ. (800 ML)

PRINCIPAL DISPLAY PANEL – 1.68 mL Packet

Henry Schein

Maxiclens

Antimicrobial

Hand Wash

With PCMX

To Order: Contact your
Henry Schein Sales Rep

0.0570 fl.oz. (1.68 ML)

Distributed by

HENRY SCHEIN, Inc.

Melville, NY 11747 USA

Made in U.S.A.

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL HAND WASH 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-5987
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q)	chloroxylenol	6.0 mg  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
coco diethanolamide (UNII: 92005F972D)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
diazolidinyl urea (UNII: H5RIZ3MPW4)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium chloride (UNII: 451W47IQ8X)
sodium laureth sulfate (UNII: BPV390UAP0)
edetate sodium (UNII: MP1J8420LU)
alpha-tocopherol acetate (UNII: 9E8X80D2L0)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-5987-01	800 mL in 1 BOX; Type 0: Not a Combination Product	03/01/2012
2	NDC: 0404-5987-02	1.68 mL in 1 POUCH; Type 0: Not a Combination Product	03/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/07/2012

Labeler - Henry Schein, Inc. (012430880)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(0404-5987)