ANTIBACTERIAL- chloroxylenol liquid

Antibacterial by

Drug Labeling and Warnings

Antibacterial 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

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

Stop use and ask 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 – 550 mL (18.6 fl. oz.) bottle

Henry Schein

Antibacterial

HAND SOAP

Spring Water

Jabón de manos
antibacteriano

Savon antibactérien
pour les mains

Foaming

18.6 fl. oz. 550 ml

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-4441
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q)	chloroxylenol	6.046 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
coco diethanolamide (UNII: 92005F972D)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
edetate sodium (UNII: MP1J8420LU)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
DMDM Hydantoin (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-4441-01	0.55 L in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/31/2013

Labeler - Henry Schein, Inc. (012430880)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(0404-4441)