Label: PLAGENTRA BABY- glycerin lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68988-070-01 - 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, Hydrogenated Polydecene, Dipropylene Glycol, Macadamia Integrifolia Seed Oil, Butylene Glycol, Cyclohexasiloxane, Betaine, Limnanthes Alba (Meadowfoam) Seed Oil, Stearic Acid, Glyceryl Stearate SE, Cyclopentasiloxane, Dimethiconol, Aloe Barbadensis Leaf Extract, Althaea Rosea Flower Extract, Arctium Lappa Root Extract, Artemisia Capillaris Leaf Extract, Calendula Officinalis Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Ocimum Basilicum (Basil) Leaf Extract, Oenothera Biennis (Evening Primrose) Seed Extract, Perilla Frutescens Leaf Extract, Prunus Mume Fruit Extract, Thymus Vulgaris (Thyme) Extract, 1,2-Hexanediol, Portulaca Oleracea Extract, Hydrolyzed Collagen, Beta-Glucan, Ceramide 3, Raffinose, Palmitoyl Pentapeptide-4, Glyceryl Stearate, Olivoyl Hydrolyzed Wheat Protein, Cetearyl Alcohol, Glyceryl Oleate, Caprylic/Capric Glycerides, Dimethicone, Citrus Paradisi (Grapefruit) Fruit Extract, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance, Potassium Hydroxide, Disodium EDTA, Xanthan Gum - 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
glycerin lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68988-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin 20 mg in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Dipropylene Glycol (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68988-070-01 100 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(68988-070)