Zeasorb Jock Itch Powder
FDA Label NDC 0316-8001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Crown Laboratories for the product Zeasorb Jock Itch (NDC 0316-8001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Use

  • Proven clinically effective in the treament of most jock itch

Warnings

For external use only.

Avoid contact with the eyes.

Do Not Use

on children under 2 years of age unless directed by a doctor.

If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center right away.

Directions

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Other Information

  • store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature]. Product settles during shipment. Package contains full net weight.

Inactive Ingredients

Aloe Barbadensis Leaf Juice Powder, Bentonite, Fragrance, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, Zea Mays (Corn) Starch

Questions?

call 1-833-279-6522

Principal Display

New & Improved

Zeasorb®AF

Antifungal Powder

with 2% Miconazole Nitrate

Cures Most Jock Itch

Relieves Itching, Burning, Scaling

Patented Odor Control Technology

Attacks and Absorbs Moisture

Talc-Free, Paraben-Free, Aluminum-Free

Dermatologist Recommended

Net wt. 2.5 oz (71g)

P12322.00

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