Active Ingredient & Purpose
Clotrimazole, USP 1%
Cura Hongo Cream
FDA Label NDC 55758-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Cura Hongo (NDC 55758-102). 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, otc - 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
Otc - Purpose
| Active ingredient | Purpose |
| Clotrimazole 1% | Antifungal |
Uses
For the treatment of most:
- athlete's foot
- jock itch
- ring worm
- itching
- scaling
- cracking
- burning
- redness
- soreness
- irritation
- discomfort
- chafing associated with jock Itch
- itchy, scaly skin between the toes
- itching, burning feet
For effective relief of:
Warnings
FOR EXTERNAL USE ONLY.
Do Not Use
- on children under 2 years, unless directed by a doctor.
When Using This Product
• avoid contact with the eyes and mouth
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 4 weeks (for athlete’s foot and 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 right away.
Directions
- wash 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
- 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, consult a doctor
- this product is not effective on the scalp or nails
Other Information
- store between 15˚- 30˚C (59˚- 85˚F)
- avoid excessive heat and humidity
TAMPER EVIDENT: Do not use if foil seal under cap is punctured, torn, or missing.
Inactive Ingredients
ceteareth-6, ceteareth-25, cetearyl ethylhexanoate, cetyl alcohol, glyceryl monostearate, peg-100 stearate, polyethylene glycol 400, propylparaben, water, white petrolatum
Questions Or Comments?
1-866-359-3478 (M-F) 9am-5pm EST or www.pharmadel.com
Distributed By/ Distribuido Por:
PHARMADEL LLC
New Castle, DE 19720 • www.pharmadel.com
+1-866-359-3478
Made in India / Hecho en India
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