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Product NDC Code | 69366-507 | ||||||
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Drug Name | Everyday diaper rash cream |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 1546589 | ||||||
Application Number | M016 | ||||||
Labeler Name | The Honest Company, Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 14%
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 soiled and wet diapers promptly, cleanse the diaper area, and allow to dry Apply diaper rash cream liberally as often as necessary to help prevent or treat irritation, with each diaper change, and 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: Helianthus Annuus (Sunflower) Seed Oil, Bis-Diglyceryl Polyacyladipate-2, Polyhydroxystearic Acid, Glyceryl Behenate, Helianthus Annuus (Sunflower) Seed Wax, Solanum Tuberosum (Potato) Starch, Caprylic/Capric Triglyceride, Linoleic Acid, Phytosterols, Phospholipids, Bisabolol, Zinc Carbonate, Water (Aqua/Eau), Stearyl Glycyrrhetinate, Tocopherol
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: Helps treat and prevent diaper rash Protects chafed skin due to 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.Everyday Diaper Rash Cream Zinc Oxide TOCOPHEROL POLYHYDROXYSTEARIC ACID (2300 MW) ZINC CARBONATE STEARYL GLYCYRRHETINATE LEVOMENOL BIS-DIGLYCERYL POLYACYLADIPATE-2 HELIANTHUS ANNUUS SEED WAX STARCH, POTATO WATER GLYCERYL DIBEHENATE MEDIUM-CHAIN TRIGLYCERIDES LINOLEIC ACID SOY STEROL LECITHIN, SOYBEAN SUNFLOWER OIL ZINC OXIDE ZINC OXIDE
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.HONEST ® EVERYDAY DIAPER RASH CREAM FRAGRANCE FREE Zinc Oxide Skin Protectant + Soothing Phyto-Blend™ Net Wt. 2.5 oz. (70.8 g) © 2022 Distributed by The Honest Company, Inc., 12130 Millennium Dr #500 Los Angeles, CA 90094 HONEST.COM • 888-862-8818 carton 2.5 oz
Tube 6 oz
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
Other information: • Will stain clothing • Store at room temperature.
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 immediately.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • do not get into eyes.
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. Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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