Label: RAPHE PHARMACEUTIQUE BIOTIN GREEN TEA PRO VITAMIN B5- pyrithione zinc liquid

  • 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 September 1, 2022

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  • Active Ingredient

    Pyrithione Zinc

  • Purpose

    Seborrheic dermatitis

  • Uses

    •Relieves scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis.
    • Helps eliminate recurrence of seborrheic dermatitis

  • Warnings

    For external use only
    Ask a doctor before use if condition covers a large area.
    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 the product as directed.
    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Apply to affected area one ml two times daily or as directed by the physician

  • Inactive ingredients

    Purified Water, Propylene Glycol, Vitamin B5, Minoxidil, Green Tea, Biotin

  • Other information

    • Store at 59° to 77°F (15° to 25°C)

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    RAPHE PHARMACEUTIQUE BIOTIN GREEN TEA PRO VITAMIN B5 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82627-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MINOXIDIL (UNII: 5965120SH1)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BIOTIN (UNII: 6SO6U10H04)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82627-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/01/2022
    Labeler - AmWiner & Raphe Holdings LLC (113433590)
    Establishment
    NameAddressID/FEIBusiness Operations
    AmWiner & Raphe Holdings LLC113433590manufacture(82627-001)
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