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Cream - Medication Information

Product NDC Code 61354-030
Drug Name

Cream

Type Brand
Active Ingredients
Zinc oxide 19.72 mg/100mg
Route TOPICAL
Dosage Form CREAM
Application Number part352
Labeler Name Oxygen Development LLC
Packages
Package NDC Code Description
61354-030-06 1 jar in 1 carton (61354-030-06) / 3 mg in 1 jar (61354-030-01)
61354-030-04 1 jar in 1 carton (61354-030-04) / 68 mg in 1 jar (61354-030-02)
61354-030-05 1 jar in 1 carton (61354-030-05) / 27 mg in 1 jar (61354-030-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients 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 liberally 15 minutes before sun exposure. Reapply at least every two hours Use a water resistant sunscreen if swimming or sweating.

Spl product data elements

Usually a list of ingredients in a drug product.
Cream Zinc Oxide COCONUT ALKANES ZINC OXIDE ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES ISOAMYL LAURATE POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM CHLORIDE SILICON DIOXIDE GLYCERYL CAPRYLATE ISOSTEARIC ACID ROSA X DAMASCENA FLOWER SUNFLOWER OIL POLYGLYCERYL-6 POLYRICINOLEATE LECITHIN, SOYBEAN POLYGLYCERYL-3 PENTARICINOLEATE GLYCERIN

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.
Secondary 3ml 61354-030-06_AW

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use Do not use on damaged on broken skin.

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 Keep out of reach of children. If swallowed, seek medical help or contact Poison Control Center.

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 When using this product, keep out of eyes. Rinse with water to remove.

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.

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