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Nivagen zinc oxide - Medication Information

Product NDC Code 75834-170
Drug Name

Nivagen zinc oxide

Type Brand
Active Ingredients
Zinc oxide 200 mg/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 198911
Application Number part347
Labeler Name Nivagen Pharmaceuticals, Inc.
Packages
Package NDC Code Description
75834-170-01 28.4 g in 1 tube (75834-170-01)
75834-170-02 56.7 g in 1 tube (75834-170-02)
75834-170-15 425 g in 1 jar (75834-170-15)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT(S) Zinc Oxide 20%

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 diaper rash: 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. ■ For poison ivy, oak, and sumac: Apply as needed.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS Cetomacrogol 1000, Cetostearyl Alcohol, Light Liquid Paraffin, White Soft Paraffin

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 ■ Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac

Purpose

Information about the drug product’s indications for use.
USE(S) Skin Protectant

Spl product data elements

Usually a list of ingredients in a drug product.
NIVAGEN ZINC OXIDE ZINC OXIDE ZINC OXIDE ZINC OXIDE CETOSTEARYL ALCOHOL CETETH-20 PETROLATUM LIGHT MINERAL OIL

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 zincoxideoneoz zincoxidetwooz zincoxidefifteenoz

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.
OTHER INFORMATION ■ Store at room temperature ■ Avoid excessiveheat

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 When using this product ■ do not get into eyes Stop use and ask a doctor if ■ conditionworsens ■ 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