Cream 18.8 mg/100mg
ZINC OXIDE · CREAM · MONAT GLOBAL CORP
Zinc oxide cream is a topical skin protectant commonly used to treat and prevent diaper rash, chafing, and minor skin irritation. It works by creating a protective barrier on the skin to shield it from moisture and irritants.
Key Facts
- Brand Name
- Cream
- Generic Name
- ZINC OXIDE
- NDC Code (Product)
78518-003- Manufacturer
- MONAT GLOBAL CORP
- Strength
- 18.8 mg/100mg
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- M020
- Marketing Start
- 09/12/2022
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?
Zinc oxide cream is a topical skin protectant commonly used to treat and prevent diaper rash, chafing, and minor skin irritation. It works by creating a protective barrier on the skin to shield it from moisture and irritants.
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 18.8 mg/100mg?
The NDC (National Drug Code) for Cream 18.8 mg/100mg is 78518-003, listed by MONAT GLOBAL CORP.
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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)