Micoclear Cream
FDA Label NDC 57237-350

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Micoclear (NDC 57237-350). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel -45g Carton

Other

Drug Facts

MICOCLEAR^TMis a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg.Lic.No.: G/25/1362

Active Ingredient

Clotrimazole 1% (w/w)

Purpose

Antifungal

Uses

cures most athlete's foot, jock itch and ringworm
relieves itching, burning, cracking, scaling, discomfort and chafing associated with jock itch

Warnings

For external use only

Otc - Do Not Use

Do not use on children under 2 years of age unless directed by a doctor.

Otc - When Using

When using this product

avoid contact with eyes.

Stop Use And Ask A Doctor If

irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks for jock itch

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

wash 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
for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails