Cream 21.76 mg/100mg
Zinc Oxide · CREAM · Oxygen Development LLC
Cream is a cream containing zinc oxide at 21.76 mg/100mg, taken topical. Manufactured by Oxygen Development LLC.
Key Facts
- Brand Name
- Cream
- Generic Name
- Zinc Oxide
- NDC Code (Product)
61354-115- Manufacturer
- Oxygen Development LLC
- Strength
- 21.76 mg/100mg
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- M020
- Marketing Start
- 10/26/2023
Recall History
KRS Global Biotechnology, Inc
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Taro Pharmaceuticals U.S.A., Inc.
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Dr. Reddy's Laboratories, Inc.
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Brands International Corporation
CGMP Deviations: lack of adequate release testing.
Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Taro Pharmaceuticals, Inc.
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Helps prevent diaper rash. Protects chafed irritated skin due to diaper rash. Helps protect from wetness that causes diaper rash. Temporarily protects and helps relieve minor skin irritation due to diaper rash. Helps treat/heal diaper rash.
Dosage & Administration
Change wet and soiled diapers promptly, cleanser the diaper area, and allow to dry. Push on the bottom to release the product. Heat the product for a few seconds on your hands and apply on baby's bottom. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. If necessary, after use, wipe off the excess on the tube contour before closing it.
Warnings
Allergens: almond For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and consult a doctor if symptoms worsen or last for more than 7 days. Keep out of reach of children. If swallowed, call a poison control centre or get edical help right away.
Frequently Asked Questions
What is Cream used for?
Cream contains Zinc Oxide. It is a cream taken topical. Consult your doctor for specific uses.
Is Cream a controlled substance?
Cream is not classified as a controlled substance by the DEA.
What is the generic name for Cream?
The generic name for Cream is Zinc Oxide. There are 12 other brand versions of Zinc Oxide.
What is the NDC code for Cream 21.76 mg/100mg?
The NDC (National Drug Code) for Cream 21.76 mg/100mg is 61354-115, listed by Oxygen Development LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)