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| Product NDC Code | 60000-020 | ||||
|---|---|---|---|---|---|
| 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 | AHOLD U.S.A., INC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 soiled 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 the 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 TOCOPHEROL 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.Compare to Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste* 40% zinc diaper rash ointment helps to heal, soothe & prevent diaper rash no paraben this product does not contain talc hypoallergenic pediatrician tested dermatologist tested no quaternium 15 NET WT 4 OZ (113 g) image description
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.*This Always My Baby Diaper Rash Ointment is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distibutor of Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste. Distributed By: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833992-3872 Quality guaranteed or your money back.
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.
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