Label: PLAGENTRA BABY SOOTHING RELIEF- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68988-100-01 - 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
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
Water, Zinc Oxide, Propanediol, Hydrogenated Polydecene, Dimethicone Crosspolymer, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Betaine, Tri-C14-15 Alkyl Citrate, Polyglutamic Acid, Stearic Acid, Glyceryl Stearate, Phaseolus Radiatus Extract, Betula Platyphylla Japonica Bark Extract, Rumex Crispus Root Extract, Scutellaria Baicalensis Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Polygonum Cuspidatum Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Sorbitan Olivate, Cetearyl Olivate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/Capric Glycerides, Caprylyl Glycol, Disodium EDTA, Butylene Glycol, Leuconostoc/Radish Root Ferment Filtrate, 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.
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
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INGREDIENTS AND APPEARANCE
PLAGENTRA BABY SOOTHING RELIEF
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68988-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 1.6 g in 80 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Zinc Oxide (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68988-100-01 80 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(68988-100)