PRIME SOURCE ANTIMICROBIAL HAND SO AP- chloroxylenol liquid

PRIME SOURCE Antimicrobial Hand So ap by

Drug Labeling and Warnings

PRIME SOURCE Antimicrobial Hand So ap by is a Otc medication manufactured, distributed, or labeled by BUNZL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Use

Handwash to help decrease bacteria on the skin

Recommended for repeated use

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

Wet hands

Apply a small amount of product and work into a lather

Rinse well and dry hands completely

Inactive ingredients

Water (Aqua), Coconut Acid, Oleic Acid, Sodium Sulfate, Ethanolamine, Cocamide MEA, Coco-Betaine, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Fragrance (Parfum), Red 33 (CI 17200), Red 40 (CI 16035)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRIME SOURCE ANTIMICROBIAL HAND SO AP 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66294-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chloroxylenol (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	Chloroxylenol	0.003 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Coconut Acid (UNII: 40U37V505D)
Oleic Acid (UNII: 2UMI9U37CP)
Sodium Sulfate (UNII: 0YPR65R21J)
MONOETHANOLAMINE (UNII: 5KV86114PT)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Coco-Betaine (UNII: 03DH2IZ3FY)
Propylene Glycol (UNII: 6DC9Q167V3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN OIL (UNII: 8470G57WFM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66294-060-37	3780 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/15/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/15/2008

Labeler - BUNZL (799540588)