ANTIMICROBIAL CLEANSER- chloroxylenol soap

ANTIMICROBIAL CLEANSER by

Drug Labeling and Warnings

ANTIMICROBIAL CLEANSER by is a Otc medication manufactured, distributed, or labeled by AFFLAB, Affiliated Laboratories, a Division of AFFLINK. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chloroxylenol 0.3% w/w

Purpose

Antimicrobial

Keep out of reach of children

If swallowed, get medical attention or contact a poison control center immediately.

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 eyes. In case of contact, rinse eyes thoroughly with water.

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

Directions

 wet hands  apply small amount of product and work into a lather   rinse well and dry hands completely

Inactive ingredients:

Water, Sodium laureth sulfate, Sodium chloride, Cocamidopropyl betaine, PEG-120 Methyl glucose dioleate, DMDM hydantoin, Linear alcohol ethoxylate, Propylene glycol, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Tetrasodium EDTA, Isopropyl myristate, Citric acid, FD&C Red #40, FD&C Red #33.

PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label AFFLAB™ Antimicrobial Lotion Cleanser Antimicrobiano Loción Limpiadora CAUTION/PRECAUCIONKeep out of reach of children.See back panel for further precautions and first aid. Net Contents 1 U.S. GALLON (3.78 Liters)      Instrucciones Atras All Hands™  Hand Care Products

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL CLEANSER 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54057-524
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C9-11 PARETH-6 (UNII: KCE0V8JT7W)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54057-524-28	3785 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/16/2013

Labeler - AFFLAB, Affiliated Laboratories, a Division of AFFLINK (023121150)