RxNorm Names

Review RxNorm Normal Forms

ANTIBACTERIAL HAND (chloroxylenol) soap
[Henry Schein, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b108cec8-c2f8-4fcf-b317-90c51469da45

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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 – 473 mL (16 fl. oz.) bottle

Henry Schein

Antibacterial

HAND SOAP

Cucumber & Aloe

Jabón de manos
antibacteriano

Savon antibactérien
pour les mains

Distributed by:
Distribuido por: Distribué par:
HENRY SCHEIN, Inc.
135 Duryea Road
Melville, NY 11747 USA

16 fl. oz. • 473 ml

PRINCIPAL DISPLAY PANEL – 473 mL (16 fl. oz.) bottle

ANTIBACTERIAL HAND
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0404-4438
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
chloroxylenol (chloroxylenol)	chloroxylenol	6.10 g in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf
coco diethanolamide
cocamidopropyl betaine
diazolidinyl urea
propylene glycol
water
sodium chloride
sodium laureth-3 sulfate
edetate sodium
.alpha.-tocopherol acetate

Packaging
#	Item Code	Package Description
1	NDC:0404-4438-01	0.473 L in 1 BOTTLE
2	NDC:0404-4438-02	0.237 L in 1 BOTTLE
3	NDC:0404-4438-03	3.785 L in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/30/2013

Labeler - Henry Schein, Inc. (012430880)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(0404-4438)

Revised: 01/2013

Document Id: 8d0f604a-b9ef-4c01-85c3-5f7d6d93528e

Set id: b108cec8-c2f8-4fcf-b317-90c51469da45

Version: 1

Effective Time: 20130130

Henry Schein, Inc.

Daily Med

Current Medication Information

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