PLAGENTRA BABY SOOTHING RELIEF- 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, 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

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)

Revised: 12/2014
Document Id: 92ee52fc-7fbe-4d53-91aa-1f346f2fdaea
Set id: 7d717593-2ae2-4b99-b09b-80da390a7d7f
Version: 2
Effective Time: 20141208
 
C.A Pharm Co., Ltd.