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NDC 24909-0218-14 Terrasil Anti-Fungal Treatment 1 g/100g Details

Terrasil Anti-Fungal Treatment 1 g/100g

Terrasil Anti-Fungal Treatment 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: 24909-0218-14
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	24909-0218
Product ID	24909-218_dffca507-5d5d-0cc3-e053-2a95a90abb09
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 Anti-Fungal Treatment
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 24909-0218-14 (24909021814)

Pricing Information	N/A
NDC Package Code	24909-218-14
Billing NDC	24909021814
Package	14 g in 1 TUBE (24909-218-14)
Marketing Start Date	2012-09-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 599e5806-6f04-4658-8b77-2cd20fc3a87d Details

Active Ingredient and Purpose

Clotrimazole 1% - Antifungal

Uses

Treats most fungal skin infections, including ringworm and tinea. 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 a layer of ointment over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Store a room temperature. May stain fabrics.

Inactive Ingredients

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

◊6x the fungal fighting power of other brands - data on file.

*may contain this ingredient.

Questions?

401-432-7750 or www.aidance.com

Product label

INGREDIENTS AND APPEARANCE

TERRASIL ANTI-FUNGAL TREATMENT

clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-218
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)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILVER OXIDE (UNII: 897WUN6G6T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ZINC OXIDE (UNII: SOI2LOH54Z)
TEA TREE OIL (UNII: VIF565UC2G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-218-14	14 g in 1 TUBE; Type 0: Not a Combination Product	09/07/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	09/07/2012

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

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-218)

Revised: 5/2022

Document Id: dffca507-5d5d-0cc3-e053-2a95a90abb09

Set id: 599e5806-6f04-4658-8b77-2cd20fc3a87d

Version: 1

Effective Time: 20220527