Label: THE ORIGINAL MANE N TAIL DAILY CONTROL ANTI DANDRUFF- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated February 10, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient Pyrithione Zinc  1%

  • PURPOSE

    Purpose  Anti-dandruff

  • INDICATIONS & USAGE

    Use - helps prevent recurrence of flaking and itching associated with dandruff.

  • WARNINGS

    Warnings For external use only

    When using this product  do not get into 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 as directed.

    Keep out of reach of children  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • For maximum dandruff control, use every time you shampoo.
    • Wet hair, massage onto scalp, rinse, repeat if desired.
    • For best results, use at least twice a week or as directed by a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Aqua (Water), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamide MEA, Coco Glucoside, Acrylates Copolymer, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Coco/Isostearamide, Dimethicone, Polyquaternium-10, Theobroma Cocao (cocoa) Seed Butter, Polyquaternium-47, Laureth-4, Laureth-7, Sodium Chloride, Fragrance (Parfum), Citric Acid, Sodium Hydroxide, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Seed Oil, Olea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Leaf Extract, Herbal Extract Blend:  Equisetum Arvense (Horsetail) Leaf Extract, Larrea Divaricata (Chaparral) Extract, Tussilago Farfara (Coltsfoot) Flower Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Trifolium Pratense (Clover) Flower Extract, Methylchloroisothiazolinone/ Methylisothiazolinone, Blue #1 (CI 42090), Yellow #5 (CI 19140).

  • The Original Mane n Tail Daily Control Anti Dandruff Shampoo

    The Original Mane n Tail Daily Control Anti Dandruff Shampoo Front LabelThe Original Mane n Tail Daily Control Anti Dandruff Shampoo Back Label

  • INGREDIENTS AND APPEARANCE
    THE ORIGINAL MANE N TAIL DAILY CONTROL ANTI DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62001-0331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC.01 g  in .01 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    POLYQUATERNIUM-47 (METHACRYLAMIDOPROPYLTRIMETHYLAMMONIUM CHLORIDE-CO-METHYL ACRYLATE-CO-ACRYLIC ACID 45:10:45; 1200000 MW) (UNII: F11YNO8FDQ)  
    LAURETH-4 (UNII: 6HQ855798J)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    LARREA DIVARICATA LEAF (UNII: I15RZ48987)  
    TUSSILAGO FARFARA (UNII: 0JXZ63016V)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62001-0331-1473 g in 1 BOTTLE, PLASTIC
    2NDC:62001-0331-210.5 g in 1 POUCH
    3NDC:62001-0331-37.1 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/20/2008
    Labeler - Straight Arrow Products Inc (061580593)
    Registrant - Straight Arrow Products Inc (061580593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Straight Arrow Products Inc061580593manufacture(62001-0331) , label(62001-0331) , pack(62001-0331)
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