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| Product NDC Code | 64068-500 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Endit zinc oxide skin protection |
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| Type | Brand | ||||||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OINTMENT | ||||||||
| RxCUI drug identifier | 198911 | ||||||||
| Application Number | M016 | ||||||||
| Labeler Name | EndIt Laboratories, Inc. | ||||||||
| 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 Ingredient Zinc Oxide 20% 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 For treatment of diaper rash: Change wet and soiled diapers promptly. Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry. Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled diapers (feces, and/or urine) may be prolonged.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol, White Petrolatum
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 rash associated with diaper use, incontinence, or exposure to feces and urin, 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.Endit zinc oxide skin protection ZINC OXIDE BORIC ACID STARCH, CORN JUNIPER TAR LANOLIN RESORCINOL WHITE PETROLATUM ZINC OXIDE ZINC CATION
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.Package Labeling:56.7 g Label
Package Labeling:113.4 g Label2
Package Labeling:227g Label3
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
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 in 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 in 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 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