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Product NDC Code | 64068-402 | ||||
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Drug Name | Endit zinc oxide skin protectant |
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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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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Zinc Oxide 20.00%
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 (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 dapers (feces, and/or urine) may be prolonged.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other 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 urine. 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 Protectant ZINC OXIDE BORIC ACID FERRIC OXIDE RED STARCH, CORN JUNIPER TAR LANOLIN RESORCINOL 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: Label
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.
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. do not get in eyes. When using this product Stop use and ask doctor if Condition worsens. Symptoms last more than 7 days or clear up and occur again within a few days.
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