Clear Men Clean and Refresh AntiDandruff

Dosage form: shampoo
Ingredients: Pyrithione Zinc 1.0mL in 100mL
Labeler: Conopco Inc. d/b/a Unilever
NDC Code: 64942-1251

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.

Clear Clean and Refresh Anti Dandruff Shampoo PDP and drug facts box

Active Ingredient

Pyrithione Zinc (1.0%)

Purpose
Antidandruff

Uses: helps prevent and control recurrence of itching and flaking associated with dandruff

Warnings
For external use only

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 of this product as directed.

Keep this and all drugs 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 best results use at least twice a week or as directed by a doctor.

Inactive Ingredients
Water (Aqua)
Sodium Laureth Sulfate
Cocamidopropyl Betaine
Sodium Chloride
Fragrance (Parfum)
Dimethiconol
Carbomer
Dimethicone
Sodium Lauroyl Isethionate
Menthol
Helianthus Annuus (Sunflower) Seed Oil
DMDM Hydantoin
Guar Hydroxypropyltrimonium Chloride
Stearic Acid
Citric Acid
Tallow Acid or Palmitic Acid
Zinc Sulfate
TEA-Dodecylbenzenesulfonate
Sodium Isethionate
Poloxamer 407
Laureth-23
Laureth-4
Tocopheryl Acetate
Prunus Amygdalus Dulcis (Sweet Almond) Oil
PPG-9
Panthenol
Lysine HCl
Hydrogenated Coconut Oil
Glycine Soja (Soybean) Oil
Methylisothiazolinone
PEG-9M
Xanthan Gum
Methylchloroisothiazolinone
Panax Ginseng Root Extract
Mentha Viridis (Spearmint) Leaf Oil
Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract
Titanium Dioxide (CI 77891)

Questions, comments?: 1-800-372-6389

PDP front

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CLEAR  MEN CLEAN AND REFRESH ANTIDANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1251
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (Pyrithione) Pyrithione Zinc1.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
TITANIUM DIOXIDE 
SODIUM LAUROYL ISETHIONATE 
DMDM HYDANTOIN 
TEA-DODECYLBENZENESULFONATE 
SUNFLOWER OIL 
CITRIC ACID MONOHYDRATE 
PPG-9 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
SPEARMINT OIL 
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) 
STEARIC ACID 
PALMITIC ACID 
ZINC SULFATE 
DIMETHICONOL (41 MPA.S) 
DIMETHICONE 
SODIUM ISETHIONATE 
POLOXAMER 407 
LAURETH-23 
LAURETH-4 
.ALPHA.-TOCOPHEROL ACETATE, D- 
ALMOND OIL 
POLYETHYLENE GLYCOL 400000 
PANTHENOL 
LYSINE HYDROCHLORIDE 
HYDROGENATED COCONUT OIL 
SOYBEAN OIL 
XANTHAN GUM 
ASIAN GINSENG 
TEA TREE OIL 
MENTHOL 
Packaging
#Item CodePackage Description
1NDC:64942-1251-1381 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H05/09/2012
Labeler - Conopco Inc. d/b/a Unilever (001375088)
Establishment
NameAddressID/FEIOperations
Unilever Supply Chain Co. d/b/a Unilever043510056manufacture

Revised: 05/2012
 
Conopco Inc. d/b/a Unilever

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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