Label: PLAGENTRA BABY SOOTHING RELIEF- dimethicone cream

  • 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 8, 2014

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

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 2%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Zinc Oxide, Propanediol, Hydrogenated Polydecene, Dimethicone Crosspolymer, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Betaine, Tri-C14-15 Alkyl Citrate, Polyglutamic Acid, Stearic Acid, Glyceryl Stearate, Phaseolus Radiatus Extract, Betula Platyphylla Japonica Bark Extract, Rumex Crispus Root Extract, Scutellaria Baicalensis Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Polygonum Cuspidatum Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Sorbitan Olivate, Cetearyl Olivate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/Capric Glycerides, Caprylyl Glycol, Disodium EDTA, Butylene Glycol, Leuconostoc/Radish Root Ferment Filtrate, Fragrance

  • PURPOSE

    Purpose: Skin Portectant

  • 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.
    4. It contains AHA. If it is your first time to use this product, take a small amount and gently apply to the skin to check if it cause andy trouble to your skin.

  • 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 BABY SOOTHING RELIEF 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68988-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.6 g  in 80 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68988-100-0180 g 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(68988-100)