AFFEX ANTIMICROBIAL FOAMING HAND SO AP- chloroxylenol liquid

AFFEX Antimicrobial Foaming Hand So ap by

Drug Labeling and Warnings

AFFEX Antimicrobial Foaming Hand So ap by is a Otc medication manufactured, distributed, or labeled by Afflink, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Uses

• 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), Alcohol, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Xylenesulfonate, Cocamide MEA, Glycerin, Isopropyl Alcohol, Lactic Acid, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Ammonium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 6 (CI 15985)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AFFEX ANTIMICROBIAL FOAMING HAND SO AP 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54057-082
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)
ALCOHOL (UNII: 3K9958V90M)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTIC ACID (UNII: 33X04XA5AT)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
JOJOBA OIL (UNII: 724GKU717M)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CORN OIL (UNII: 8470G57WFM)
AMMONIUM SULFATE (UNII: SU46BAM238)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54057-082-42	1250 mL in 1 PACKAGE; Type 0: Not a Combination Product	08/15/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/15/2013

Labeler - Afflink, Inc. (023121150)