Evercare Antifungal Treatment Super Absorbent Powder
FDA Label NDC 83099-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Paneffort, Llc for the product Evercare Antifungal Treatment Super Absorbent Powder (NDC 83099-000). 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 drug facts, active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor, 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
for the cure of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tea corporis) for effective relief of itching, cracking, burning, scaling and discomfort
Warnings
For external use only.
Flammable, Do not use while smoking or near heat or flame.
Do Not Use
on children under 2 years of age unless directed by a doctor
When Using This Product
- avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
Stop Use And Ask A Doctor
if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
clean the affected area& dry thoroughly apply a thin layerof the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attenting to spaces between the toes;wear wellfitting, ventilated shoes, & change shoes& socks at least once daily for athlete's foot&ringworm, use daily for 4 weeks, for jock itch, 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 between 59-86 °F
- lightly shake bottle to loosen settled powder
Inactive Ingredients
corn starch, sodium bicarbonate, kaolin, zinc oxide, calamine
Package Labeling:
Label01 (Label01)
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