PLAGENTRA INTENSIVE CARE- 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 2%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Glycerin, Propanediol, Cetearyl Alcohol, Betaine, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Macadamia Integrifolia Seed Oil, Beeswax, Butylene Glycol, Trehalose, Tri-C14-15 Alkyl Citrate, Hydrogenated Polydecene, Limnanthes Alba (Meadowfoam) Seed Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Polyacrylate-13, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Ceramide 3, Polyisobutene, Polysorbate 20, C8-12 Acid Triglyceride, Cholesterol, Hydrogenated Lecithin, Phytosphingosine, Oleic Acid, Lactic Acid, Panthenol, 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 Offcinalis (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

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 cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68988-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68988-040-01100 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(68988-040)

Revised: 12/2014
Document Id: fc769023-e438-4ac4-95e0-119339d9da25
Set id: 9ddefd34-66ef-4f2d-9e65-7a2c3d9aeb45
Version: 2
Effective Time: 20141205
 
C.A Pharm Co., Ltd.