MEDACLEAR- zinc pyrithione shampoo 
Amico Educational Concepts, Inc.

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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Medaclear Shampoo

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:

Symptom Relief for:

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

8oz Label

Distributed By

 John Amico Haircare Products

4731 W. 136th Street, Crestwood, IL 60445

www.johnamico.com

MEDACLEAR 
zinc pyrithione shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51290-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC15.0 g  in 1.0 L
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51290-011-080.24 L in 1 BOTTLE
2NDC:51290-011-320.95 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H09/08/2010
Labeler - Amico Educational Concepts, Inc. (127642333)
Registrant - Continental Manufacturing Chemist, Inc. (005278007)
Establishment
NameAddressID/FEIBusiness Operations
Continental Manufacturing Chemist, Inc.005278007MANUFACTURE(51290-011)

Revised: 12/2011
Document Id: 6b58da56-8aba-4b5a-8d23-f026a9715f32
Set id: 7302048e-36ad-49ef-9551-6e7c2adb1137
Version: 3
Effective Time: 20111229
 
Amico Educational Concepts, Inc.