Label: HUM- glycerin cream

  • Category: HUMAN OTC DRUG LABEL

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 10, 2013

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  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Caprylic / CapricTriglyceride, Cetyl Ethylhexanoate, Glycerin, MacadamiaIntegrifolia Seed Oil, Cyclopentasiloxane, Cyclohexasiloxane, Cetearyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Cetearyl Glucoside, Magnolia Kobus Bark Extract, Propolis Extract, Camellia Sinensis Leaf Extract, Thujopsis Dolabrata BRANCH Extract, Citrus Grandis (Grapefruit) Fruit Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Salix Alba(Willow) Bark Extract, Poly glyceryl-3 Methylglucose Distearate, Glyceryl Stearate, PEG-100 Stearate, Sphingolipids, Phospholipids, Lecithin, Tocopherol, Carbomer, Triethanolamine, Forsythia Suspensa Fruit Extract, Paeonia Albiflora Root Extract, Rehmannia Chinensis Root Extract, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Xanthium Strumarium Fruit Extract, Eriobotrya Japonica Leaf Extract, Sanguisorba Officinalis Root Extract, Polygonum Cuspidatum Root Extract, Kaempferia Galanga Root Extract, Phaseolus Radiatus Seed Extract, Yeast Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Velvet Extract, Centella Asiatica Extract, Carthamus Tinctorius (Safflower) SeedOil, Coix Lacryma-Jobi Ma-yuen (Job's Tears) Seed Oil, Beeswax, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Glyceryl Caprate, Propagermanium, Panthenol, Dimethicone, Laureth-7, C13-14 Isoparaffin, Polyacrylamide, Tocopheryl Acetate, Dipotassium Glycyrrhizate, Allantoin, Lactobacillus/Soybean Ferment Extract, Stearyl Glycyrrhetinate, Sorbitan Sesquioleate, Sodium Hyaluronate, Phenoxyethanol,Adenosine, Disodium EDTA, Ceramide 3,Hydrogenated Lecithin


  • PURPOSE

    skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    apply a certain quantity to the skin every morning and night


  • WARNINGS

    A. Please stop using the product in anyone of the following cases:
    1) Rash, swelling, itching, irritation, and other abnormal reactions on the skin after using the product.
    2) When the abnormalities above appear on the skin due to direct sunlight, etc.
    B. Do NOT use on a scar, or skin affected by dermatitis, eczema, etc.
    C. Notes for Storage
    1) Make sure to close the lid after use.
    2) Keep away from babies and children.
    3) Do not store in high/low temperature or under direct sun light.
    Abnormal products will be compensated for according to “Standard for Consumer Dispute Resolution” by Fair Trade Commission


  • DOSAGE & ADMINISTRATION

    for topical use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    HUM 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61254-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAMELLIA SINENSIS ROOT (UNII: 8H54O0V2K3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61254-1001-150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/10/2013
    Labeler - Happy Sonic Global Co., Ltd. (688735115)
    Registrant - Happy Sonic Global Co., Ltd. (688735115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Happy Sonic Global Co., Ltd.688735115manufacture(61254-1001)