MEDACLEAR- zinc pyrithione shampoo

Medaclear by

Drug Labeling and Warnings

Medaclear by is a Otc medication manufactured, distributed, or labeled by Amico Educational Concepts, Inc., Continental Manufacturing Chemist, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

 Zinc Pyrithione 1.5%

Purpose

 Antidandruff and Antisebborrheic Dermatitis

Use

 helps prevent the symptoms from dandruff and/or Seborrheic Dermatitus such as itching, flaking, irritation and redness.

Warnings

For external use only

Ask a doctor before use

 if you have seborrheic dermatitis that covers a large area of the body.

On children under 2 years of age.

When using this product

 avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

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

Wet hair, massage into scalp, rinse, repeat if desired.  For maximum dandruff control, use every time you shampoo.  For best results, use twice a week, or as directed by a doctor.

Other information

 Shampoo Scalp & Skin Treatment

Medicated Formula

Treatment for:

• Flaking Scalp & Skin
• Oily Scalp
• Itchy Scalp

Symptom Relief for:

• Seborrheic Dermatitus and Psoriasis

Inactive ingredients

 Citric Acid, Cocamide DEA, DMDM Hydantoin, Dyes, Ethylene Glycol Monostearate, Fragrance, Purified Water, Sodium Chloride, TEA Lauryl Sulfate

Questions?

 1-800-JohnAmico

Principal Display Panel

 8oz label:

8oz Label

Distributed By

 John Amico Haircare Products

4731 W. 136th Street, Crestwood, IL 60445

www.johnamico.com

INGREDIENTS AND APPEARANCE

MEDACLEAR 
zinc pyrithione shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51290-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	15.0 g  in 1.0 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCOL STEARATE (UNII: 0324G66D0E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51290-011-08	0.24 L in 1 BOTTLE
2	NDC: 51290-011-32	0.95 L in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	09/08/2010

Labeler - Amico Educational Concepts, Inc. (127642333)

Registrant - Continental Manufacturing Chemist, Inc. (005278007)

Establishment
Name	Address	ID/FEI	Business Operations
Continental Manufacturing Chemist, Inc.		005278007	MANUFACTURE(51290-011)