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NDC 24909-0215-20 Terrasil Tinea Treatment Maximum Strength 1 g/100g Details

Terrasil Tinea Treatment Maximum Strength 1 g/100g

Terrasil Tinea Treatment Maximum Strength is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Aidance Skincare & Topical Solutions, LLC. The primary component is CLOTRIMAZOLE.

MedlinePlus Drug Summary

Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Related Packages: 24909-0215-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	24909-0215
Product ID	24909-215_df62a3f7-1a81-7dff-e053-2995a90af540
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Terrasil Tinea Treatment Maximum Strength
Proprietary Name Suffix	n/a
Non-Proprietary Name	Clotrimazole
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	CLOTRIMAZOLE
Labeler Name	Aidance Skincare & Topical Solutions, LLC
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24909-0215-20 (24909021520)

Pricing Information	N/A
NDC Package Code	24909-215-20
Billing NDC	24909021520
Package	200 g in 1 TUBE (24909-215-20)
Marketing Start Date	2021-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 983678a4-5ac7-4903-9e4b-ac28da857758 Details

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Clears up tinea fungal infections including tinea versicolor, tinea corporis, tinea cruris and tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.

Warnings

For external use only. Do not use on 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 4 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.

Directions

Wash and dry affected skin. Apply ointment over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Store at room temperature. May stain fabrics.

Inactive Ingredients

beeswax (organic), bentonite (volcanic clay)*, cedarwood oil, cottonseed oil*, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver stearate, sunflower oil*, zinc oxide

♦6X the fungal fighting power of other brands - data on file.

*may contain this ingredient.

Questions?

401-432-7750 or learn more at www.aidance.com

Product label

INGREDIENTS AND APPEARANCE

TERRASIL TINEA TREATMENT MAXIMUM STRENGTH

clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-215
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
BENTONITE (UNII: A3N5ZCN45C)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILVER OXIDE (UNII: 897WUN6G6T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-215-20	200 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	01/01/2021

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-215)

Revised: 5/2022

Document Id: df62a3f7-1a81-7dff-e053-2995a90af540

Set id: 983678a4-5ac7-4903-9e4b-ac28da857758

Version: 1

Effective Time: 20220519