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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Treats most jock itch (tinea cruris). For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort associated with jock itch.

Warnings

For external use only. Do not use on children under 2 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.

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 (organic), jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver stearate, tea tree oil, witch hazel, zinc oxide

PRINCIPAL DISPLAY PANEL - 14 g tube

Jock Itch Treatment Max

TERRASIL JOCK-ITCH TREATMENT MAX
clotrimazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-100
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
SILVER STEARATE (UNII: 4H6PCL92ZN)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
TEA TREE OIL (UNII: VIF565UC2G)
WHITE WAX (UNII: 7G1J5DA97F)
WITCH HAZEL (UNII: 101I4J0U34)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-100-14	14 g in 1 JAR; Type 1: Convenience Kit of Co-Package	05/12/2014	12/31/2018
2	NDC:24909-100-50	50 g in 1 TUBE; Type 0: Not a Combination Product	05/12/2014
3	NDC:24909-100-44	44 g in 1 JAR; Type 0: Not a Combination Product	05/12/2014	05/23/2019
4	NDC:24909-100-15	14 g in 1 TUBE; Type 1: Convenience Kit of Co-Package	05/12/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	05/12/2014

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

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare and Topical Solution, LLC		018950611	manufacture(24909-100)