RxNorm Names

Review RxNorm Normal Forms

SANISUDS F-7500 (benzalkonium chloride) soap
[Palmer Fixture Company]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=00d0e5b0-09aa-417f-9dc3-5dea59e57340

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

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only.
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
Stop use and ask a doctor if irritation or redness develops, or if condition persists 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

Pump a small amount of foam into palm of hand.
Rub thoroughly over all surfaces of both hands.
Rub hands together briskly until dry.

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance

Case Label - 3 x 1200 mL Bags

SANISUDS F-7500
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48417-750
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (Benzalkonium)	Benzalkonium Chloride	1.00 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
CETRIMONIUM CHLORIDE
LAURTRIMONIUM CHLORIDE
DIHYDROXYETHYL COCAMINE OXIDE
CITRIC ACID MONOHYDRATE
GLYCERETH-17 COCOATE

Product Characteristics
Color	white (water white - colorless, dispensed as a white foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:48417-750-02	3 in 1 BOX
1		1200 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/07/2009

Labeler - Palmer Fixture Company (185454241)

Revised: 09/2012

Document Id: 0b2a3149-eb69-48b0-bc7e-911bead54818

Set id: 00d0e5b0-09aa-417f-9dc3-5dea59e57340

Version: 2

Effective Time: 20120927

Palmer Fixture Company

Daily Med

Current Medication Information

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