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Zinc oxide 20% - Medication Information

Product NDC Code 69396-086
Drug Name

Zinc oxide 20%

Type Brand
Active Ingredients
Zinc oxide .2 g/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 198911
Application Number M016
Labeler Name Trifecta Pharmaceuticals USA
Packages
Package NDC Code Description
69396-086-02 1 tube in 1 box (69396-086-02) / 60 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient 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 Apply ointment liberally as often as necessary For the treatment of diaper rash, change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Cetomacrogol 1000, Cetostearyl alcohol, Light Mineral Oil, 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 Protects skin Protects and releives chafed skin due to diaper rash - helps seal out wetness Dries the oozing and weeping of poison ivy, oak and 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 20% Zinc Oxide WHITE PETROLATUM CETETH-20 LIGHT MINERAL OIL CETOSTEARYL ALCOHOL 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.
Globe Zinc Oxide Ointment 2oz India Rev09 042323 CDER

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 Distributed By: Trifecta Pharmaceuticals USA, LLC.® 101 NE Third Avenue, Ste. 1500 Ft. Lauderdale, FL. 33301, USA. www.trifecta-pharma.com

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 the reach of children If swallowed, get medical help or contact a Poison Control Center immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions Call 1-888-296-9067

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 Doctor if Stop use and ask doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Store at controlled room temperature 15° - 30°C (59° - 86°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 avoid contact with eyes

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