ANTIMICROBIAL CLEANSER- chloroxylenol soap
AFFLAB, Affiliated Laboratories, a Division of AFFLINK

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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/PRECAUCION
Keep 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

image description

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)

Revised: 10/2013
Document Id: faeb5c8e-d956-4ad4-a4ef-6f5b5443e97f
Set id: 3d2e19f3-bd99-47bd-a330-ded018e51f4b
Version: 1
Effective Time: 20131016
AFFLAB, Affiliated Laboratories, a Division of AFFLINK