Active Ingredient
Active Ingredient: Dimethicone 1%
Plagentra Baby
FDA Label NDC 68988-060
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by C.a Pharm Co., Ltd. for the product Plagentra Baby (NDC 68988-060). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients:
Water, Glycerin, Cyclopentasiloxane, Sorbitan Stearate, Cetyl Alcohol, Stearic Acid, Phytosqualane, Isohexadecane, Triethylhexanoin, Prunus Armeniaca (Apricot) Kernel Oil, Ulmus Davidiana Root Extract, Amaranthus Caudatus Seed Extract, Piper Methysticum Leaf/Root/Stem Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Portulaca Oleracea Extract, Paeonia Albiflora Root Extract, Cnidium Officinale Root Extract, Pueraria Thunbergiana Root Extract, Soluble Collagen, Aloe Barbadensis Leaf Juice, Hydrogenated Lecithin, Sodium Hyaluronate, Polysorbate 60, Tromethamine, Sorbitan Sesquioleate, Sucrose Cocoate, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Polymethacrylate, Carbomer, Caprylhydroxamic Acid, Tocopheryl Acetate, Disodium EDTA, Dipotassium Glycyrrhizate, Butylene Glycol, Panthenol, Xanthan Gum, Folic Acid, Ceramide 3, Cholesterol, Raffinose, Polyglutamic Acid, Phytosphingosine, Palmitoyl Pentapeptide-4, 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.
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.
* Please review the disclaimer below.
