CLEAR MEN 2 IN 1 CLEAN AND REFRESH ANTIDANDRUFF- pyrithione zinc shampoo 
Conopco Inc. d/b/a Unilever

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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Clear Men 2 in 1 Clean and Refresh Anti Dandruff Shampoo and Conditioner 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
Clear Men  2 in 1 Clean and Refresh AD Shampoo and Conditioner front

back
Clear Men 2 in 1 Clean and Refresh AD Shampoo and Conditioner back
CLEAR  MEN 2 IN 1 CLEAN AND REFRESH ANTIDANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione - UNII:6GK82EC25D) Pyrithione Zinc1.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM LAUROYL ISETHIONATE (UNII: M590021Z02)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PPG-9 (UNII: I29VQH0G0B)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SPEARMINT OIL (UNII: C3M81465G5)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PALMITIC ACID (UNII: 2V16EO95H1)  
ZINC SULFATE (UNII: 89DS0H96TB)  
DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
LAURETH-23 (UNII: N72LMW566G)  
LAURETH-4 (UNII: 6HQ855798J)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ALMOND OIL (UNII: 66YXD4DKO9)  
POLYETHYLENE GLYCOL 400000 (UNII: 439X29GCJZ)  
PANTHENOL (UNII: WV9CM0O67Z)  
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
SOYBEAN OIL (UNII: 241ATL177A)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
TEA TREE OIL (UNII: VIF565UC2G)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64942-1250-1381 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/FEIBusiness Operations
Unilever Supply Chain Co. d/b/a Unilever043510056manufacture

Revised: 5/2012
Document Id: 36f8d93d-53bf-4c91-8aba-4a35ac4fcc6f
Set id: 40215a43-8595-4c0e-ae92-5696e27df8c3
Version: 1
Effective Time: 20120503
 
Conopco Inc. d/b/a Unilever