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Product NDC Code | 70793-010 | ||||||
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Drug Name | Zoey naturals diaper cream |
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Type | Brand | ||||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 245660 | ||||||
Application Number | M016 | ||||||
Labeler Name | Absolutely Natural | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 15%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Change wet and soiled diapers promptly, cleanse diaper area and allow to dry • Apply cream liberally with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (INCI): Cocoa nucifera (coconut) oil, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed oil, cera alba (beeswax), ricinus communis (castor) seed oil, carthamus tinctorius (safflower) seed oil, vitis vinifera (grape) seed oil, maranta arundinacea (arrowroot) root powder, theobroma cacao (cocoa) seed butter, mangifera indica (mango) seed butter, persea gratissima (avocado) oil, kaolin clay, tocopheryl acetate (vitamin E).
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • ZOEY Naturals DIAPER CREAM helps treat and prevent diaper rash. Protect minor skin irritation associated with diaper rash and helps seal out wetness.
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.ZOEY NATURALS DIAPER Cream Zinc Oxide ZINC OXIDE ZINC CATION COCONUT OIL SHEA BUTTER SUNFLOWER OIL WHITE WAX CASTOR OIL SAFFLOWER OIL GRAPE SEED OIL MARANTA ARUNDINACEA ROOT COCOA BUTTER MANGIFERA INDICA SEED BUTTER AVOCADO OIL KAOLIN .ALPHA.-TOCOPHEROL ACETATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging DIAPER Cream
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Fragrance Free SKIN PROTECTANT HYPOALLERGENIC, NO HARSH CHEMICALS, THERAPEUTIC RELIEF, ZINC BLEND made for babies loved by mamas www.Zoey-Naturals.com Manufactured by: Absolutely Natural, Inc. 640 Atlantis Road, Melbourne, FL 32904 Distributed by: Zoey Naturals 640 Atlantis Road, Melbourne, FL 32904
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call us! 800-848-8498
Storage and handling
Information about safe storage and handling of the drug product.Other information • Will stain clothing • Store at room temperature
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. When using this product • do not get into eyes. • rinse with water to remove. Stop use and ask doctor if • condition worsens • rash or irritation develops and lasts for more than 7 days. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API