RxNorm Names

Review RxNorm Normal Forms

RUGBY ANTI-DANDRUFF (selenium sulfide) shampoo
[Rugby Laboratories, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph 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

Selenium sulfide 1%

Purpose

Anti-dandruff

Use

relieves scalp flaking and itching due to dandruff and seborrheic dermatitis, and helps prevent their recurrence

Warnings

For external use only

Ask a doctor before use if you have seborrheic dermatitis in areas other than the scalp

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
for color-treated or permed hair, it is especially important to rinse thoroughly.

Stop use and ask a doctor if condition worsens or does not improve after regular use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

shake well
shampoo, then rinse thoroughly
for best results, use at least twice a week or as directed by a doctor

Other information

store at room temperature

Inactive ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamidopropyl betaine, cocamide DEA, magnesium aluminum silicate, hypromellose, fragrance, menthol, DMDM hydantoin, citric acid, sodium chloride, FD&C blue no. 1, D&C red no. 33

Questions or comments?

Call 1-800-645-2158 9 am - 5 pm ET,
Monday - Friday

PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label

COMPARE TO
ACTIVE INGREDIENT IN
SELSUN BLUE®*

Rugby®
NDC 0536-1995-53

New
Formula

ANTI •
DANDRUFF
SHAMPOO

Selenium Sulfide 1 %

BLUE FORMULA
FOR NORMAL HAIR

Helps to control dandruff symptoms
Leaves hair soft and manageable

05-2675

7 fl oz
(207 mL)

SATISFACTION GUARANTEED
Rugby
• OR YOUR MONEY BACK •

Principal Display Panel - 207 mL Bottle Label

RUGBY ANTI-DANDRUFF
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1995
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Selenium Sulfide (Selenium Sulfide)	Selenium Sulfide	10 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water
Ammonium Laureth-2 Sulfate
Ammonium Lauryl Sulfate
Cocamidopropyl Betaine
Coco Diethanolamide
Magnesium Aluminum Silicate
Hypromelloses
Menthol
DMDM Hydantoin
Citric Acid Monohydrate
Sodium Chloride
Fd&C Blue No. 1
D&C Red No. 33

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:0536-1995-53	207 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	05/01/2012

Labeler - Rugby Laboratories, Inc. (191427277)

Registrant - Garcoa, Inc. (103039178)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		103039178	MANUFACTURE(0536-1995)

Revised: 01/2013

Document Id: 7dc73cf8-3e47-4b91-8b05-f9ce4a2dd460

Set id: f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2

Version: 1

Effective Time: 20130130

Rugby Laboratories, Inc.

Daily Med

Current Medication Information

Options

Additional Resources