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NDC 24909-0208-50 Terrasil Antifungal Cream Maximum Strength 1 g/100g Details

Terrasil Antifungal Cream Maximum Strength 1 g/100g

Terrasil Antifungal Cream Maximum Strength is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions. 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: 24909-0208-50
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	24909-0208
Product ID	24909-208_d84acf50-9701-a4ad-e053-2a95a90afd75
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 Antifungal Cream Maximum Strength
Proprietary Name Suffix	n/a
Non-Proprietary Name	Clotrimazole
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	CLOTRIMAZOLE
Labeler Name	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions
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 24909-0208-50 (24909020850)

Pricing Information	N/A
NDC Package Code	24909-208-50
Billing NDC	24909020850
Package	50 g in 1 TUBE (24909-208-50)
Marketing Start Date	2022-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d0108ec5-8fd9-45d9-8c75-a222ebf82a0e Details

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Cures 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 thin layer of cream over the 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

cotton seed oil, distilled water, emulsifying wax, Jojoba seed oil, peppermint oil, shea butter, silver stearate, sorbic acid, tea tree oil, zinc oxide

Questions?

401-432-7750 or www.aidance.com

Product label

INGREDIENTS AND APPEARANCE

TERRASIL ANTIFUNGAL CREAM MAXIMUM STRENGTH

clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-208
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
COTTONSEED OIL (UNII: H3E878020N)
PEPPERMINT OIL (UNII: AV092KU4JH)
SILVER OXIDE (UNII: 897WUN6G6T)
TEA TREE OIL (UNII: VIF565UC2G)
ZINC OXIDE (UNII: SOI2LOH54Z)
JOJOBA OIL (UNII: 724GKU717M)
WATER (UNII: 059QF0KO0R)
SORBIC ACID (UNII: X045WJ989B)
SHEA BUTTER (UNII: K49155WL9Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-208-50	50 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	01/01/2022

Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions		018950611	manufacture(24909-208)

Revised: 2/2022

Document Id: d84acf50-9701-a4ad-e053-2a95a90afd75

Set id: d0108ec5-8fd9-45d9-8c75-a222ebf82a0e

Version: 2

Effective Time: 20220218