PLAGENTRA MOTHERS BELLY- 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, 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

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)

Revised: 12/2014
Document Id: ff0a4d93-9b22-4912-9cee-14bf4939d7c5
Set id: 9caf7daf-b656-4a6f-8fc5-9a15aa19e9e2
Version: 2
Effective Time: 20141205
 
C.A Pharm Co., Ltd.