PLAGENTRA BABY SOOTHING RELIEF- dimethicone cream

PLAGENTRA BABY SOOTHING RELIEF by

Drug Labeling and Warnings

PLAGENTRA BABY SOOTHING RELIEF by is a Otc medication manufactured, distributed, or labeled by C.A Pharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PLAGENTRA BABY SOOTHING RELIEF 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68988-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1.6 g  in 80 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Zinc Oxide (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68988-100-01	80 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2014

Labeler - C.A Pharm Co., Ltd. (688198385)

Registrant - C.A Pharm Co., Ltd. (688198385)

Establishment
Name	Address	ID/FEI	Business Operations
C.A Pharm Co., Ltd.		688198385	manufacture(68988-100)