CLEAR MEN CITRUS FRESH HYDRATION 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 Citrus Fresh Hydration Anti Dandruff Shampoo and Conditioner

Active Ingredient:

Pyrithione Zinc (1.0%)

Purpose:

Anti-Dandruff

Use: 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, Fragrance (Parfum), Sodium Chloride, Dimethiconol, Carbomer, Dimethicone, Sodium Lauroyl Isethionate, Helianthus Annuus (Sunflower) Seed Oil, DMDM Hydantoin, Guar Hydroxypropyltrimonium Chloride, Stearic Acid, Citric Acid, Tallow Acid, Zinc Sulfate, TEA-Dodecylbenzenesulfonate, Sodium Isethionate, Poloxamer 407, Laureth-23, Laureth-4, Propylene Glycol, Tocopheryl Acetate, Hydrogenated Coconut Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glycine Soja (Soybean) Oil, Lysine HCl, Panthenol, PPG-9, Methylisothiazolinone, PEG-9M, Xanthan Gum, Butylene Glycol, Citrus Medica Limonum (Lemon) Peel Extract, Methylchloroisothiazolinone, Iodopropynyl Butylcarbamate, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Panax Ginseng Root Extract, Mentha Viridis (Spearmint) Leaf Oil, Titanium Dioxide (CI 77891)

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

12.9 PDP

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CLEAR  MEN CITRUS FRESH HYDRATION ANTIDANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1313
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc1.0 g  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)  
TRIETHANOLAMINE 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)  
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)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LEMON PEEL (UNII: 72O054U628)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64942-1313-1381 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/01/2013
Labeler - Conopco Inc. d/b/a Unilever (001375088)
Establishment
NameAddressID/FEIBusiness Operations
Unilever Supply Chain Co. d/b/a Unilever043510056manufacture(64942-1313)

Revised: 9/2013
Document Id: 1c4d8f5f-0c28-4c41-a824-39be04accd69
Set id: 368494eb-cccc-41f8-978b-40a2e2c0af8d
Version: 1
Effective Time: 20130926
 
Conopco Inc. d/b/a Unilever