PLAGENTRA INTENSIVE CARE- dimethicone lotion 
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 2%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propanediol, Macadamia Integrifolia Seed Oil, Cetearyl Alcohol, Betaine, 1,2-Hexanediol, Hydrogenated Polydecene, Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Butylene Glycol, Glyceryl Oleate, Olivoyl Hydrolyzed Wheat Protein, PEG-100 Stearate, Stearic Acid, Panthenol, Allantoin, Tocopheryl Acetate, Ceramide 3, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, C8-12 Acid Triglyceride, Cholesterol, Hydrogenated Lecithin, Phytosphingosine, Oleic Acid, Lactic Acid, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Panax Ginseng Callus Culture Extract, Phellinus Linteus Mycelium Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Lactobacillus/Soybean Ferment Extract, Ethoxydiglycol, Musa sapientum (banana) flower extract, Terminalia Chebula Fruit Extract, Disodium EDTA, Potassium Hydroxide, Xanthan Gum

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

PLAGENTRA INTENSIVE CARE 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68988-050
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:68988-050-01150 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(68988-050)

Revised: 12/2014
Document Id: 103494f4-734e-4bf4-b958-17632f70339d
Set id: c6306bc4-76a9-4fd4-ae89-d838f204d12e
Version: 2
Effective Time: 20141205
 
C.A Pharm Co., Ltd.