Label: PLAGENTRA INTENSIVE CARE- dimethicone lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 68988-050-01 - Packager: C.A Pharm Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 5, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Inactive Ingredients:
Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propanediol, Macadamia Integrifolia Seed Oil, Cetearyl Alcohol, Betaine, 1,2-Hexanediol, Hydrogenated Polydecene, Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Butylene Glycol, Glyceryl Oleate, Olivoyl Hydrolyzed Wheat Protein, PEG-100 Stearate, Stearic Acid, Panthenol, Allantoin, Tocopheryl Acetate, Ceramide 3, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, C8-12 Acid Triglyceride, Cholesterol, Hydrogenated Lecithin, Phytosphingosine, Oleic Acid, Lactic Acid, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Panax Ginseng Callus Culture Extract, Phellinus Linteus Mycelium Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Lactobacillus/Soybean Ferment Extract, Ethoxydiglycol, Musa sapientum (banana) flower extract, Terminalia Chebula Fruit Extract, Disodium EDTA, Potassium Hydroxide, Xanthan Gum - PURPOSE
-
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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PLAGENTRA INTENSIVE CARE
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68988-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 3 mg in 150 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68988-050-01 150 mL 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(68988-050)