Label: CALENDULA DIAPER RASH CREAM- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0164-2189-49, 0164-2189-53, 0164-2189-54 - Packager: Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled
- 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 June 27, 2013
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- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients (USA) / Non-Medicinal Ingredients (Canada):
Beeswax, Calendula Flower Extract, Cananga Oil, Chamomile Flower Extract, Citrus Aurantium Leafy Twig (Petitgrain) Oil, Clary Sage Oil, Glyceryl Linoleate, Hectorite, Lanolin, Lavender Oil, Orange Oil, Rosemary Oil, Sage Oil, Sesame Seed Oil, Styrax Benzoin Resin, Sweet Almond Oil, Water.
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CALENDULA DIAPER RASH CREAM
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0164-2189 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CANANGA OIL (UNII: 8YOY78GNNX) CHAMOMILE (UNII: FGL3685T2X) CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D) CLARY SAGE OIL (UNII: 87L0D4U3M0) GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L) HECTORITE (UNII: 08X4KI73EZ) LANOLIN (UNII: 7EV65EAW6H) LAVENDER OIL (UNII: ZBP1YXW0H8) ORANGE OIL (UNII: AKN3KSD11B) ROSEMARY OIL (UNII: 8LGU7VM393) SAGE OIL (UNII: U27K0H1H2O) SESAME OIL (UNII: QX10HYY4QV) STYRAX BENZOIN RESIN (UNII: FE663Z8IRO) ALMOND OIL (UNII: 66YXD4DKO9) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0164-2189-53 81 g in 1 TUBE 2 NDC:0164-2189-54 10.8 g in 1 TUBE 3 NDC:0164-2189-49 1.5 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/27/2013 Labeler - Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled (315541862) Establishment Name Address ID/FEI Business Operations Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled 315541862 manufacture(0164-2189)
