Label: ROOTSALLO ADVANCED SCALP CARE HAIR- salicylic acid, menthol, panthenol shampoo

  • 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 December 30, 2021

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

  • ACTIVE INGREDIENTS

    Salicylic Acid 0.25%
    Menthol 0.3%
    Panthenol 0.2%

  • PURPOSE

    Deep Cleansing, Refreshing Scalp, Anti Hair-Loss

  • Uses

    Certified shampoo for hair loss
    Helps improve scalp care and gives the conditioning effect.

  • Warnings

    For external use only.
    In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic consult a dermatologist immediately.
    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    Wet hair and take an appropriate amount of shampoo and mix it into your hands. Massage throughout wet hair and scalp for 1~3 minutes gently and rinse thoroughly.

  • Other Information

    Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

  • Questions

    www.rootsallo.com 82-31-429-0588

  • Inactive ingredients

    Water, Lauryl Glucoside, Butylene Glycol, Sodium methyl cocoyl taurate, Sodium cocoyl alaninate, Chamaecyparis Obtusa Oil, 1,2-Hexanediol, Dipropylene Glycol, Sodium chloride, Citric Acid, Polyquaternium-10, Polianthes tuberosa extract, Ethylhexylglycerin, Silicone Quaternium-22, Hydroxyethyl Urea, Disodium EDTA, Hydrolyzed Wheat Protein, Hydrolyzed Keratin, Polyglyceryl-3 Caprate, Rehmannia Chinensis Root Extract, Cornus Officinalis Fruit Extract, Dioscorea Japonica Root Extract, Alisma Orientale Tuber Extract, Poria Cocos Sclerotium Extract, Paeonia Suffruticosa Root Extract, Avena Sativa (Oat) Protein Extract, Gaultheria Procumbens (Wintergreen) Leaf Extract, Sambucus Nigra Flower Extract, Malva Sylvestris (Mallow) Extract, Melissa Officinalis Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Achillea Millefolium Extract, Eucalyptus Globulus Leaf Extract, Cryptomeria Japonica Leaf Extract, Hyssopus Officinalis Extract, Saccharomyces Cerevisiae Extract, Sodium Benzoate, Phenoxyethanol, Methylparaben, Propylparaben

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ROOTSALLO ADVANCED SCALP CARE HAIR 
    salicylic acid, menthol, panthenol shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82450-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.25 g  in 100 mL
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol0.3 g  in 100 mL
    Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Lauryl Glucoside (UNII: 76LN7P7UCU)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82450-040-021 in 1 CARTON12/01/2021
    1NDC:82450-040-01350 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2021
    Labeler - rootsallo Qwell (695495466)
    Registrant - rootsallo Qwell (695495466)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONGBANG COSMETIC CO.,LTD.694452564manufacture(82450-040)