PLAGENTRA BABY- dimethicone cream 
C.A Pharm Co., Ltd.

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.

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ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Glycerin, Cyclopentasiloxane, Sorbitan Stearate, Cetyl Alcohol, Stearic Acid, Phytosqualane, Isohexadecane, Triethylhexanoin, Prunus Armeniaca (Apricot) Kernel Oil, Ulmus Davidiana Root Extract, Amaranthus Caudatus Seed Extract, Piper Methysticum Leaf/Root/Stem Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Portulaca Oleracea Extract, Paeonia Albiflora Root Extract, Cnidium Officinale Root Extract, Pueraria Thunbergiana Root Extract, Soluble Collagen, Aloe Barbadensis Leaf Juice, Hydrogenated Lecithin, Sodium Hyaluronate, Polysorbate 60, Tromethamine, Sorbitan Sesquioleate, Sucrose Cocoate, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Polymethacrylate, Carbomer, Caprylhydroxamic Acid, Tocopheryl Acetate, Disodium EDTA, Dipotassium Glycyrrhizate, Butylene Glycol, Panthenol, Xanthan Gum, Folic Acid, Ceramide 3, Cholesterol, Raffinose, Polyglutamic Acid, Phytosphingosine, Palmitoyl Pentapeptide-4, 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.

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

PLAGENTRA BABY 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68988-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68988-060-01100 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(68988-060)

Revised: 12/2014
Document Id: a501ba90-bab6-41ad-87db-9e1156474990
Set id: edeb3d0f-1119-471a-8d7b-2a23f64850c2
Version: 2
Effective Time: 20141208
 
C.A Pharm Co., Ltd.