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| Product NDC Code | 68001-533 | ||||
|---|---|---|---|---|---|
| Drug Name | Zinc oxide |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 198911 | ||||
| Application Number | M016 | ||||
| Labeler Name | BluePoint Laboratories | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 20% w/w
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 poison ivy, oak, and sumac: apply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 20, 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 • Dries the oozing and weeping of poison: • Ivy • Oak • Sumac
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 Skin Protectant LIGHT MINERAL OIL CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER WHITE PETROLATUM ZINC OXIDE ZINC OXIDE Zinc Oxide Skin Protectant LIGHT MINERAL OIL CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER WHITE PETROLATUM 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.Tube and carton 30 g Carton label 30 g Tube label 30 g
Tube and carton 60 g Carton label 60 g Tube label 60 g
Jar Label 454 g Jar Label 454 g
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal. Store at room temperature. Preserve in well-closed container. See crimp of tube or carton for Lot number and Expiry Date.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Contact 1-800-707-4621 Gopaldas Visram & Company Limited. Plot No. A327, T.T.C. Indl. Area, M.I.D.C. Mahape, Navi Mumbai- 400710. For BluePoint Laboratories
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 • The condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days • You are allergic to any of these ingredients
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 • Do not use over large areas of the body
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 • Do not use over large areas of the body Stop use and ask a doctor if • The condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days • You are allergic to any of these ingredients 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