Label: PLAGENTRA MOTHERS BELLY- dimethicone 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 December 5, 2014

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

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 2%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Glycerin, Caprylic/Capric Triglyceride, Saccharomyces Ferment Filtrate, Dipropylene Glycol, Ethylhexyl Palmitate, Hydrogenated Polydecene, 1,2-Hexanediol, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Stearic Acid, Tri-C14-15 Alkyl Citrate, Cetearyl Olivate, Sorbitan Olivate, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Sodium Hyaluronate, Musa Sapientum (Banana) Fruit Extract, Centella Asiatica Extract, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Offcinalis (Rosemary) Leaf Extract, Glyceryl Stearate, Carbomer, Ethoxydiglycol, Disodium EDTA, Potassium Hydroxide

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:
    1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen:
    1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.
    2. Do not apply the product to wounds or skin with dermatitis such as eczema.
    3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of babies and children.

  • INDICATIONS & USAGE

    Indication and usage:
    1) Tighten the lid after using it. 2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3) Use it in the morning or evening after shower.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Take appropriate amount to the entire face and body, gently massage and tapping until absorbed.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PLAGENTRA MOTHERS BELLY 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68988-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone3 mg  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68988-010-01150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2014
    Labeler - C.A Pharm Co., Ltd. (688198385)
    Registrant - C.A Pharm Co., Ltd. (688198385)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.A Pharm Co., Ltd.688198385manufacture(68988-010)