Label: PELO BAUM HAIR REVITALIZING- allantoin shampoo

  • 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 May 12, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.5%

  • INACTIVE INGREDIENT

    Inactive ingredient: Water (Aqua), Sodium Laureth Sulfate, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Propylene Glycol, Glycerin, Sodium Chloride, Phenoxyethanol, Sodium Benzoate, Polyquaternium-7, Fragrance (Parfum), Menthol, Arginine, PEG-150 Pentaerythrityl Tetrastearate, Polyquaternium-10, Ginkgo Biloba Leaf Extract, Polygala Tenuifolia Root Extract, Portulaca Oleracea Extract, Disodium EDTA, Panthenol, Citric Acid, Morus Alba Bark Extract, Polygonum Fagopyrum (Buckwheat) Seed Extract, Benzophenone-9, Polygonum Multiflorum Root Extract, Thuja Orientalis Seed Extract, Niacinamide, Yellow 6 (CI 15985), Hydrogenated Lecithin, Glycine Soja (Soybean) Oil, Biotin, Acid Violet 43 (CI 60730), Sodium Oleate, Oligopeptide-41, Octapeptide-2, Oligopeptide-54, Oxo Azaandrostene Carboxyloyl Decapeptide-18

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warning: For external use only, do not swallow. In case of accidental ingestion, seek medical assistance. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and consult a doctor if rash or irritation occurs. Do not apply directly to a wound or open cut. Keep out of reach of children. Store at room temperature (below 25℃).

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses: Clinically proven formula that helps promote longer, thicker and healthier hair. Designed to stimulate and fortify the hair and scalp condition, creating a healthy environment for hair restoration.

  • Directions

    Directions: Wet hair thoroughly, gently lather shampoo throughout hair and scalp. Gently massage scalp for 15 seconds. Leave on hair for 30 seconds and rinse out.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PELO BAUM HAIR REVITALIZING 
    allantoin shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60716-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.75 g  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60716-050-021 in 1 CARTON05/01/2017
    1NDC:60716-050-01150 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 finalpart34705/01/2017
    Labeler - Caregen Co.,Ltd. (689850365)
    Registrant - Caregen Co.,Ltd. (689850365)
    Establishment
    NameAddressID/FEIBusiness Operations
    Caregen Co.,Ltd.689850365manufacture(60716-050)