TERRASIL ANTIFUNGAL CLEANSING BAR- clotrimazole soap

terrasil Antifungal Cleansing Bar by

Drug Labeling and Warnings

terrasil Antifungal Cleansing Bar by is a Otc medication manufactured, distributed, or labeled by Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Clotrimazole 1%

Pupose

Antifungal

Uses

Treats Athlete’s foot (tinea pedis), Jock itch (tinea cruris), Ringworm (tinea corporis). Relieves Itching, burning, cracking.

Warnings

For external use only.
Do not use on children under two years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, or 2 weeks for jock itch, discontinue use and consult a doctor.

Keep out of reach of children.

If swallowed, call poison control or seek medical help.

Directions

Wash affected area well, rinse after 2 minutes. Dry thoroughly.
Use twice daily (morning and night) or as directed by a doctor.
Supervise children in the use of this product.
For athlete's foot: Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.
This product is not effective on the scalp or nails.
Use with Terrasil Antifungal Ointment for best results.

Inactive ingredients

beeswax, citric acid, glycerin, jojoba oil, lavender oil, magnesium oxide, MCT oil, peppermint oil, propylene glycol, silver stearate, sodium chloride, sodium citrate, sodium laurate, sodium laureth sulfate, sodium lauryl sulfate, sodium myristate, sodium oleate, sodium olivate, sodium shea butterate, sodium stearate, sorbitol, tea tree oil, tetrasodium etidronate, tetrasodium iminodisuccinate, titanium dioxide, water, zinc oxide

Questions?

401-432-7750 or www.aidance.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TERRASIL ANTIFUNGAL CLEANSING BAR 
clotrimazole soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-037
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID (UNII: 2968PHW8QP)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEPPERMINT OIL (UNII: AV092KU4JH)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURATE (UNII: K146MR5EXO)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
SODIUM OLEATE (UNII: 399SL044HN)
SODIUM OLIVATE (UNII: ND5Y5M6ZUT)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SORBITOL (UNII: 506T60A25R)
TEA TREE OIL (UNII: VIF565UC2G)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)
SILVER STEARATE (UNII: 4H6PCL92ZN)
TETRASODIUM IMINODISUCCINATE (UNII: GYS41J2635)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-037-75	75 g in 1 BOX; Type 0: Not a Combination Product	10/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/02/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions		018950611	manufacture(24909-037)