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| Product NDC Code | 0316-0231 | ||||
|---|---|---|---|---|---|
| Drug Name | Zeasorb |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | POWDER | ||||
| RxCUI drug identifier | 998461, 1437793 |
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| Application Number | M005 | ||||
| Labeler Name | Crown Laboratories | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Miconazole nitrate 2%
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 (Athlete's Foot) clean 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 pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks if condition persists longer, consult a doctor this product is not effective on the scalp or nails
Directions (Jock Itch) clean 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aldioxa, Chloroxylenol, Croscarmellose Sodium, Fragrance, Imidazolidinyl Urea, Magnesium Stearate, Microcrystalline Cellulose, Sodium Acrylates Crosspolymer-2
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.Use (Athlete's Foot) for the cure of most athlete's foot
Use (Jock Itch) for the cure of most jock itch
Purpose
Information about the drug product’s indications for use.Purpose antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Zeasorb miconazole nitrate SODIUM ACRYLATES CROSSPOLYMER-2 ALDIOXA CHLOROXYLENOL IMIDUREA MICONAZOLE NITRATE MICONAZOLE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM CROSCARMELLOSE white to off-white Zeasorb miconazole nitrate ALDIOXA CHLOROXYLENOL IMIDUREA MICONAZOLE NITRATE MICONAZOLE CROSCARMELLOSE SODIUM CROSCARMELLOSE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM ACRYLATES CROSSPOLYMER-2 white to off-white
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.Principal Display Panel NDC 0316-0231-25 Zeasorb ® AF ANTIFUNGAL TREATMENT Miconazole Nitrate 2% Super Absorbent Powder New & Improved cures most athlete's foot Absorbs & Repels Moisture Relieves: Itching Burning Scaling Dermatologist Recommended Net wt. 2.5 oz (71 g) Front Label: P11546.01 athlete's foot
Principal Display Panel NDC 0316-0232-25 Zeasorb ® AF ANTIFUNGAL TREATMENT Miconazole Nitrate 2% Super Absorbent Powder New & Improved cures most jock itch Absorbs & Repels Moisture Relieves: Itching Burning Scaling Dermatologist Recommended Net wt. 2.5 oz (71 g) Front Label: P11551.01 jock itch
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 on children under 2 years of age unless directed by a doctor.
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. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call 1-833-279-6522 Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 ZEASORB is a registered trademark of Crown Laboratories, Inc. P11552.01 ©2020 Crown Laboratories, Inc.
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 a doctor if (Athlete's Foot) irritation occurs or there is no improvement within 4 weeks.
Stop use and ask a doctor if (Jock Itch) irritation occurs or there is no improvement within 2 weeks.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature]. Product settles during shipment. Package contains full net weight.
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. Avoid contact with the eyes. Do not use on children under 2 years of age unless directed by a doctor. Stop use and ask a doctor if (Athlete's Foot) irritation occurs or there is no improvement within 4 weeks. Stop use and ask a doctor if (Jock Itch) irritation occurs or there is no improvement within 2 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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