CLEAR 2 IN 1 SCALP COMFORT 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 2 in 1 Scalp Comfort 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.  Repeat if desired.  For best results use at least twice a week or as directed by a doctor.

Inactive Ingredients:

Questions, Comments?

1-800-372-6389

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CLEAR  2 IN 1 SCALP COMFORT ANTIDANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc1 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)  
TALLOW ACID, BEEF (UNII: 5U9XZ261ER)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64942-1309-1647 mL in 1 CONTAINER
2NDC:64942-1309-2381 mL in 1 CONTAINER
3NDC:64942-1309-350 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/01/2013
Labeler - Conopco Inc. d/b/a Unilever (001375088)
Establishment
NameAddressID/FEIBusiness Operations
Unilever Supply Chain Co. d/b/a Unilever043510056manufacture(64942-1309)
Establishment
NameAddressID/FEIBusiness Operations
Marietta Corp111359712manufacture(64942-1309)
Establishment
NameAddressID/FEIBusiness Operations
Marietta Corp010765394manufacture(64942-1309)

Revised: 4/2014
Document Id: 93ad0552-1f3a-42c4-987a-6d374ce2058b
Set id: 227d5cab-19f5-4416-be44-e3b4f3a05df2
Version: 2
Effective Time: 20140423
 
Conopco Inc. d/b/a Unilever