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| Product NDC Code | 68016-128 | ||||
|---|---|---|---|---|---|
| Drug Name | Diaperrashointment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 244638 | ||||
| Application Number | part347 | ||||
| Labeler Name | Pharmacy Value Alliance, LLC | ||||
| 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 and 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 BHA, Cod liver oil (high in vitamin A and D), Frangrance, Lanolin, Mineral Oil, Methylparaben, Petrolatum, Purified water, Talc, Tartrazine yellow #4 (FD and C yellow #4)
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 protect skin from 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.DiaperRashOintment Zinc Oxide POLYSORBATE 80 ALPHA-TOCOPHEROL ACETATE GLYCERYL MONOSTEARATE PROPYLPARABEN METHYLPARABEN ALOE VERA LEAF PETROLATUM YELLOW WAX STEARIC ACID ZINC OXIDE ZINC OXIDE MINERAL OIL WATER
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 Packaging
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
Helps treat and prevent diaper rash. Protects skin. Relieves Chafing. Promotes Healing Distributed by: Pharmacy Value Alliance, LLC. 407 East Lancaster Avenue, Wayne, PA. 19087 USA www.emersongroup.com
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 the 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 with a few days
Storage and handling
Information about safe storage and handling of the drug product.Other Information: Store at controlled room temperature 20° - 25°C (68° - 77°F)
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 Avoid contact with eyes
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