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| Product NDC Code | 30142-226 | ||||
|---|---|---|---|---|---|
| Drug Name | Creamy diaper rash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 899863 | ||||
| Application Number | part347 | ||||
| Labeler Name | Kroger Co. | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reaction DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc oxide 13% Purpose Skin protectant
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 water, mineral oil, petrolatum, beeswax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxystearate, Aloe barbadensis leaf juice, glycerin, tropolone, tocopheryl acetate, 1,2-hexanediol, caprylyl glycol, magnesium sulfate, potassium hydroxide, phenoxyethanol
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.Creamy Diaper Rash Zinc Oxide ZINC OXIDE ZINC OXIDE WATER MINERAL OIL PETROLATUM YELLOW WAX DIMETHICONE SORBITAN SESQUIOLEATE MICROCRYSTALLINE WAX PEG-30 DIPOLYHYDROXYSTEARATE ALOE VERA LEAF GLYCERIN TROPOLONE .ALPHA.-TOCOPHEROL ACETATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL MAGNESIUM SULFATE MONOHYDRATE POTASSIUM HYDROXIDE PHENOXYETHANOL
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 COMFORTS FOR BABY Skin Protectant Creamy Diaper Rash Ointment Aloe, Vitamin E, + Zinc Oxide Seals out wetness Hypoallergenic Creamy formula Fresh Scent NET WT 4 OZ (113 g) image description
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.Stop use and ask a doctor 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 25⁰ C (68⁰ - 77⁰ 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 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 Stop use and ask a doctor 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