MedPath

Terrasil Anti-Fungal Treatment

24909-106 terrasil Antifungal Treatment Max

Approved
Approval ID

db356cc8-f473-4eb2-b8d8-72606fca9dc0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions

DUNS: 018950611

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clotrimazole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24909-106
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Clotrimazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (14)

YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
PALM OILInactive
Code: 5QUO05548Z
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
SAGE OILInactive
Code: U27K0H1H2O
Classification: IACT
SILVER STEARATEInactive
Code: 4H6PCL92ZN
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
WITCH HAZELInactive
Code: 101I4J0U34
Classification: IACT
ZINC OXIDEInactive
Code: SOI2LOH54Z
Classification: IACT
CLOTRIMAZOLEActive
Quantity: 1 g in 100 g
Code: G07GZ97H65
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/25/2023

Product label

Tube

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/13/2023

Uses

Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/25/2023

Active Ingredient

Clotrimazole 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/9/2012

Purpose

Antifungal

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/29/2018

WARNINGS SECTION

LOINC: 34071-1Updated: 10/13/2023

Warnings

For external use only.Do not useon children under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a physician.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/13/2023

Directions

Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil*, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced)*, witch hazel, zinc oxide

*may contain this ingredient

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 10/13/2023

Other information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

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