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Drug Facts
Dist. by: Scholl’s Wellness Company LLC
Parsippany, NJ 07054
Made in Canada.
Terbinafine Hydrochloride Cream
FDA Label NDC 73469-7215
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scholl's Wellness Company Llc for the product Terbinafine Hydrochloride (NDC 73469-7215). 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, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Terbinafine hydrochloride 1%
Purpose
Antifungal
Uses
- cures most athlete's foot (tinea pedis)
- cures most jock itch (tinea cruris) and ringworm (tinea corporis)
- relieves itching, burning, cracking and scaling which accompany these conditions
Warnings
For external use only
Do Not Use
- on nails or scalp
- in or near the mouth or eyes
- for vaginal yeast infections
Otc - When Using
When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if too much irritation occurs or gets worse
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
|  Image (Terbinafine 01)  Image (Terbinafine 02) |
Other Information
TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
- store at controlled room temperature 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredients
benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol
Questions?
call 1-866-360-3226
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