PLAGENTRA BABY SOOTHING RELIEF

Manufacturer
C.A Pharm Co., Ltd.
Effective date
2014-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:41:02

Label at a glance#

ProductPLAGENTRA BABY SOOTHING RELIEF
Active ingredientDimethicone
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Dimethicone 2%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Skin Portectant

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of babies and children.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

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 & ADMINISTRATION SECTION

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 cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244642dimethicone 2 % Topical CreamPSN2
244642dimethicone 20 MG/ML Topical CreamSCD2
244642dimethicone 2 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130889422000092GTIN-13: 0889422000092
EAN-13: 0889422000092
GTIN-12: 889422000092
UPC-A: 889422000092
GTIN storage (14 digits): 00889422000092
plagentra baby soothing relief carton.jpg
QR code linkQR Codewww.capharm.co.kr/plagentra baby soothing relief carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68988-100-012020-01-31C16284748780-19d75b9d0-eaac-f424-e053-dadaa90a57ce7d717593-2ae2-4b99-b09b-80da390a7d7f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68988-100-01PLAGENTRA BABY SOOTHING RELIEF80 g in 1 CARTONCREAM802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68988-100PLAGENTRA BABY SOOTHING RELIEF (DIMETHICONE) CREAM [C.A PHARM CO., LTD.]2Legacy NDC, 1 package rows20141208_7d717593-2ae2-4b99-b09b-80da390a7d7f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1O2
DIMETHICONEACTIVE MOIETY92RU3N3Y1O2
WaterINACTIVE INGREDIENT059QF0KO0R2
Zinc OxideINACTIVE INGREDIENTSOI2LOH54Z2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68988-10068988-100-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
Water059QF0KO0RIACT
Zinc OxideSOI2LOH54ZIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Zinc OxideZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Zinc OxideZINC OXIDESOI2LOH54ZSOLUTION / INTRAVENOUS3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
Zinc OxideZINC OXIDESOI2LOH54ZSUPPOSITORY / RECTAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates
Zinc OxideZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
Zinc OxideZINC OXIDESOI2LOH54ZINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
Zinc OxideZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
92ee52fc-7fbe-4d53-91aa-1f346f2fdaea7d717593-2ae2-4b99-b09b-80da390a7d7f2014-12-08WarningsExact identifier
spl id: 92ee52fc-7fbe-4d53-91aa-1f346f2fdaea
spl set id: 7d717593-2ae2-4b99-b09b-80da390a7d7f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.