Label: ANTI DANDRUFF- keranique anti dandruff shampoo lotion

  • 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 November 6, 2022

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

  • Active Ingredients

    Salicylic Acid 3.0%

  • Uses

    Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

  • Purpose

    Anti-Dandruff, Anti-Seborrheic Dermatitis, Anti-Psoriasis

  • Warnings

    Because we utilize as many naturally derived ingredients as
    possible, our products may vary in color over time and with each new batch
    we make. These natural variations do not in any way affect the quality of
    efficacy of the product.
    █ For external use only. █ Ask a doctor before use if you have a condition
    that covers a large area of the body █ Avoid contact with eyes. If contact
    occurs, rinse eyes thoroughly with water. █ Stop use and ask a doctor if the
    condition worsens or does not improve after regular use of this product as
    directed. 

  • Keep out of reach of children.

    █ Keep out of the reach of children. If swallowed, get medical help
    or contact the 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, leave on scalp for
    several minutes, rinse, repeat if desired.

  • Other Information

    Store in a cool, dry place

  • Inactive Ingredients

    Water (Aqua), Sodium Coco-Sulfate,
    Cocamidopropyl Betaine, Glycerin, Aloe Barbadensis Leaf Juice, Fragrance,
    Decyl Glucoside, Camellia Sinensis Leaf Extract, Hydrolyzed Quinoa,
    Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet
    Almond) Oil, Xylitol, Hydrolyzed Soy Protein, Triethyl Citrate, Gluconolactone,
    Polyquaternium-7, Phenoxyethanol, Benzyl Alcohol, Sodium Benzoate,
    Potassium Sorbate.

  • Questions or Comments?

    Call toll free 1-888-237-4131 or visit www.keranique.com

  • Principal Display Panel

    70550-329

  • INGREDIENTS AND APPEARANCE
    ANTI DANDRUFF 
    keranique anti dandruff shampoo lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70550-329
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCINE (UNII: TE7660XO1C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    SIMMONDSIA CHINENSIS WHOLE (UNII: DFM16KFA82)  
    PRUNUS DULCIS WHOLE (UNII: X3EC86GF0Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70550-329-011 in 1 CARTON11/06/2022
    1240 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 finalpart358H11/06/2022
    Labeler - Profectus Beauty, LLC (118310694)