TERRASIL TINEA TREATMENT  MAX- clotrimazole ointment 
Aidance Skincare & Topical Solutions, LLC

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Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

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.

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 4 weeks, discontinue use and consult a physician.

Directions

Wash and dry affected skin. Apply a thin layer of ointment 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

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, witch hazel, zinc oxide

Product label

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TERRASIL TINEA TREATMENT   MAX
clotrimazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCONUT OIL (UNII: Q9L0O73W7L)  
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PALM OIL (UNII: 5QUO05548Z)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SAGE OIL (UNII: U27K0H1H2O)  
SILVER STEARATE (UNII: 4H6PCL92ZN)  
TEA TREE OIL (UNII: VIF565UC2G)  
WITCH HAZEL (UNII: 101I4J0U34)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-104-1414 g in 1 JAR; Type 0: Not a Combination Product05/12/201405/21/2018
2NDC:24909-104-4444 g in 1 JAR; Type 0: Not a Combination Product05/12/201405/21/2018
3NDC:24909-104-1514 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
4NDC:24909-104-5050 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
5NDC:24909-104-20200 g in 1 JAR; Type 0: Not a Combination Product05/12/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00505/12/2014
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-104)

Revised: 12/2023
Document Id: 0b76ea15-247a-3afa-e063-6294a90a9d3f
Set id: d0b14dcb-89a7-42f6-b6ae-8f19c4e6aaaa
Version: 6
Effective Time: 20231201
 
Aidance Skincare & Topical Solutions, LLC