Label: PLAGENTRA MOTHERS BELLY- dimethicone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68988-010-01 - Packager: C.A Pharm Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
Water, Glycerin, Caprylic/Capric Triglyceride, Saccharomyces Ferment Filtrate, Dipropylene Glycol, Ethylhexyl Palmitate, Hydrogenated Polydecene, 1,2-Hexanediol, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Stearic Acid, Tri-C14-15 Alkyl Citrate, Cetearyl Olivate, Sorbitan Olivate, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Sodium Hyaluronate, Musa Sapientum (Banana) Fruit Extract, Centella Asiatica Extract, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Offcinalis (Rosemary) Leaf Extract, Glyceryl Stearate, Carbomer, Ethoxydiglycol, Disodium EDTA, Potassium Hydroxide - 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 MOTHERS BELLY
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68988-010 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:68988-010-01 150 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(68988-010)