Active Ingredient
Miconazole Nitrate 2%
Touchless Care Antifungal
FDA Label NDC 69502-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Crawford Healthcare, Inc. for the product Touchless Care Antifungal (NDC 69502-001). 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, indications, warnings, stop use and ask a doctor if, 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
Purpose
Antifungal
Indications
- Treats jock itch, ringworm and athlete's foot
- For the treatment of most superficial skin irritations caused by yeast (Candida albicans). Follow a physician's instructions when treating Candida.
Warnings
Do not use on children under 2 years of age unless directed by a doctor. Not intended for ingestion. Do not use for diaper rash. For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor If
- irritation develops
- there is no improvement within 4 weeks for athlete's foot or ringworm or within 2 weeks for jock itch.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a poison control center immediately.
Directions
- Cleanse the affected area and allow to dry.
- Shake bottle well before use.
- Spray 4-6 inches from skin twice daily (morning and night) or as directed by a physician. No rub-in is required.
- For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, contact a doctor. This product is not effective on the scalp or nails.
Other Information
Store at 59 oF - 87 oF (15 oC - 30 oC)
Inactive Ingredients
Cyclomethicone, Dimethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, White Petrolatum, Zinc Oxide
Other
Distributed by: Crawford Healthcare, Inc. Doylestown, PA 18901
Touchless Care is a registered trademark of Crawford Woundcare Ltd.
© Crawford Healthcare Ltd., 2016
www.crawfordhealthcare.com/us
1-855-522-2211
Made in the USA
Package Label
Antifungal label
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