Label: PLAGENTRA BABY- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68988-060-01 - 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 8, 2014
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- ACTIVE INGREDIENT
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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
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLAGENTRA BABY
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68988-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 1 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68988-060-01 100 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(68988-060)