Label: MANE N TAIL DAILY CONTROL ANTI-DANDRUFF- pyrithione zinc shampoo, suspension

  • 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 October 5, 2010

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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

    • 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, Fragrance (Parfum), Sodium Hydroxide, 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, PEG-8 Amodimethicone, Methylchloroisothiazolinone/Methylisothiazolinone, Blue #1 (CI 42090), Yellow #5 (CI 19140).

  • PRINCIPAL DISPLAY PANEL

    AD Shampoo Front Label

    AD Shampoo Back Label

  • INGREDIENTS AND APPEARANCE
    MANE N TAIL DAILY CONTROL ANTI-DANDRUFF 
    pyrithione zinc shampoo, suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62001-0319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LAURETH-4 (UNII: 6HQ855798J)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    LARREA TRIDENTATA TOP (UNII: PK0TXD049P)  
    TUSSILAGO FARFARA (UNII: 0JXZ63016V)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    RED CLOVER (UNII: L9153EKV2Y)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62001-0319-17257.6 g in 1 BOTTLE, PLASTIC
    2NDC:62001-0319-2453.6 g in 1 POUCH
    3NDC:62001-0319-3158.76 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, Inc.061580593manufacture
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