Label: HEAD AND SHOULDERS HAIR THICKENING SYSTEM WITH BIOTIN- pyrithione zinc kit

  • 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 December 2, 2021

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  • Active ingredient

    Pyrithione zinc 1%

  • SPL UNCLASSIFIED SECTION

    Hair Thickening

    Step 1 2in1

    with BIOTIN

    Cleans to restore fullness to thinning hair, while helping maintain a healthy scalp.

    pyrithione zinc dandruff shampoo + conditioner

    Step 1: Use 2in1 to massage into wet hair and scalp. Lather and rinse.

    Drug Facts

  • Purpose

    Anti-dandruff

  • Uses

    helps prevent recurrence of flaking and itching 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

    • for best results use at least twice a week or as directed by a doctor.
    • for maximum dandruff control, use every time you shampoo
    • shake before use.
    • wet hair, massage onto scalp, rinse, repeat if desired.
  • Inactive ingredients

    Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, menthol, guar hydroxypropyltrimonium chloride,magnesium carbonate hydroxide, biotin, methylchloroisothiazolinone, methylisothiazolinone.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Hair Thickening

    Step 2 Treatment

    with BIOTIN

    Thickens existing hair, while helping maintain a healthy scalp.

    pyrithione zinc dandruff treatment

    Step 2: Use treatment out of shower. Apply directly to roots and scalp.

    Drug Facts

  • Active ingredient

    Pyrithione zinc 0.1%

  • Purpose

    Anti-dandruff

  • Uses

    helps prevent recurrence of flaking and itching 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

    • apply to affected areas one to four times daily or as directed by a doctor.
    • place package tip close to scalp on damp or dry hair and use 15 sprays to cover the entire scalp. Massage into scalp with fingertips. DO NOT rinse off.
  • Inactive ingredients

    Water, niacinamide, PEG-40 hydrogenated castor oil, phenoxyethanol, caffeine, bis-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, fragrance, glycerin, benzyl alcohol, menthol, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin, mentha piperita (peppermint) oil, mentha arvensis leaf oil, biotin.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - Kit Package

    head &
    shoulders ®

    HAIR THICKENING SYSTEM

    WITH BIOTIN

    head & shoulders

    pyrithione zinc dandruff shampoo + conditioner

    2in1 Hair Thickening Step 1

    with Biotin

    23.7 FL OZ (700 mL)

    head &
    shoulders ®

    pyrithione zinc dandruff treatment

    Treatment

    Hair Thickening Step 2

    with Biotin

    6.7 FL OZ (200 mL)

    HS1HS2

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS HAIR THICKENING SYSTEM  WITH BIOTIN
    pyrithione zinc kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-593
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-593-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product10/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 700 mL
    Part 21 BOTTLE, PLASTIC 200 mL
    Part 1 of 2
    HEAD AND SHOULDERS 2IN1 HAIR THICKENING STEP 1 
    pyrithione zinc lotion/shampoo
    Product Information
    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
    MENTHOL (UNII: L7T10EIP3A)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BIOTIN (UNII: 6SO6U10H04)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/01/2021
    Part 2 of 2
    HEAD AND SHOULDERS TREATMENT HAIR THICKENING STEP 2 
    pyrithione zinc liquid
    Product Information
    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
    EDETOL (UNII: Q4R969U9FR)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    BIOTIN (UNII: 6SO6U10H04)  
    BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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