Active Ingredients
Miconazole nitrate 2%
Gerigentle Miconazole Nitrate Powder
FDA Label NDC 69771-165
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-gentle Corporation for the product Gerigentle Miconazole Nitrate (NDC 69771-165). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
fFor the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) ■Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet
Warnings
For external use only.
Do Not Use
: ■On children under 2 years of age unless directed by a doctor ■For diaper rash
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor If
■Irritation occurs
■There is no improvement within 2 weeks when used for the treatment of jock itch ■There is no improvement within 4 weeks when used for athlete's foot or ringworm
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- clean the affected area & 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
- for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, 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 at room temperature
Inactive Ingredients
Colloidal Anhyhdrous Silica, Talcum Powder
Questions?
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