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| Product NDC Code | 83514-0020 | ||||
|---|---|---|---|---|---|
| Drug Name | Zinc oxide |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 244638 | ||||
| Application Number | M016 | ||||
| Labeler Name | AB Brands, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Zinc oxide 40%
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 soilded diapers promptly cleanse the diaper area allow to dry apply ointment liberally as often as necessary, 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 petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance
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.Zinc oxide Zinc oxide PETROLATUM COD LIVER OIL LANOLIN STARCH, CORN GLYCERIN SORBITAN SESQUIOLEATE YELLOW WAX .ALPHA.-TOCOPHEROL ACETATE 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.Principal display panel NEW! Aquation DIAPER RASH OINTMENT Skin Protectant 40% ZINC OXIDE GLYCERIN VITAMIN E Helps treat diaper rash Soothes irritated skin and blocks moisture No parabens, phthalates, talc or dyes MAX STRENGTH NET WT 4 OZ/113 g mm01
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.Claims - Side panel RELIEF YOU CAN FEEL 40% ZINC OXIDE 5-IN-1 COMFORT HELPS TREAT PREVENT PROTECT SOOTHE RELIEVE
Back panel - Claims & Adverse reactions Aquation Diaper Rash Ointment Made with 40% Zinc Oxide to help treat and protect chafed skin and skin irritations caused by rash. Aquation spreads easily to seal out wetness forming a protective layer to relieve discomfort. 40% ZINC OXIDE Skin protectant made with GLYCERIN VITAMIN E HYPOALLERGENIC PEDIATRICIAN TESTED DERMATOLOGIST TESTED No parabens, phthalates, talc, dyes or DEA *Maximum strength zinc oxide diaper rash ointment available under product monograph. WOMEN OWNED WOMEN OWNED www.aquationcare.com Aquation is a registed trademark of AB Brands, LLC. Made in the USA with domestic & foreign materials. American-owned. Not tested on animals. Distributed by AB Brands, LLC Dallas, TX 75219
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 1-877-662-3288
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
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20⁰ and 25⁰C (68⁰ and 77⁰F)
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
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