Label: ANTI HAIR LOSS- pyrithione zinc, biotin soap

  • NDC Code(s): 72100-100-01, 72100-100-02
  • Packager: Golden B America, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 1, 2018

If you are a consumer or patient please visit this version.

  • Active ingredients

    Zinc pyrithione (2.1%)

    Biotin (0.06%)

  • Purpose

    Anti-dandruff

    Anti-hairloss

  • Uses

    Helps prevent hair loss and strengthen hair root and thicken hair. Helps to treat symptoms caused by dandruff

  • Warnings

    For external use only

    Do not use when scalp is red, inflamed, irritated, or painful

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
    • do not apply directly to wound or open cut

    Stop use and ask a doctor if

    • rash or irritation on scalp in develops and lasts
    • condition does not improve or worsen after regular use of this product as directed

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    1. Wet soap to generate foam to cover desired part of scalp.

    2. Massage foam well into the hair and scalp by rubbing gently.

    3. Thoroughly massage 3-5 min to generate more soap then rinse.

    4. If hair is dry and stiff after wash use conditioner and rinse.

    5. Repeat 2-3 times daily as needed.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Inactive ingredients

    Nicotinamide, Zinc Oxide, Shea Butter, Chamomile Extract, Arginine, Grape Seed Oil, Tea Tree Oil, Aloe Extract, Gardenia Seed Extract, Green Tea Extract, Mugwort Extract, Licorice Root Extract, Shrubby Sophora Extract, morus alba bark extract, Tocophenol, Dexpanthenol, Sekken Soji, Charcoal

  • Anti Hair Loss Soap

    anti hair loss soap

  • INGREDIENTS AND APPEARANCE
    ANTI HAIR LOSS 
    pyrithione zinc, biotin soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72100-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.1 g  in 100 g
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.06 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ARGININE (UNII: 94ZLA3W45F)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALOE (UNII: V5VD430YW9)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    LICORICE (UNII: 61ZBX54883)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72100-100-021 in 1 PACKAGE03/13/2018
    1NDC:72100-100-01100 g in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/13/2018
    Labeler - Golden B America, LLC. (081015296)
    Registrant - Golden B America, LLC. (081015296)
    Establishment
    NameAddressID/FEIBusiness Operations
    Golden B America, LLC.081015296relabel(72100-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Asan C&s631139649manufacture(72100-100)