drug facts

drug facts
SPL v2
SPL
SPL Set ID e63fb1f4-cf30-4d13-b14b-63f7c6a74ba6
Route
topical
Published
Effective Date 2018-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1.0 g)
Inactive Ingredients
bentonite cottonseed oil jojoba oil magnesium oxide peppermint oil silver oxide stearic acid tea tree oil white wax zinc oxide

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-06-27

Purpose

Antifungal

Description

Clotrimazole 1%


Medication Information

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.

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.

Purpose

Antifungal

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

beeswax (organic), cotton seed oil, bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid, tea tree oil, zinc oxide.

Description

Clotrimazole 1%

Section 53413-1

Questions? 401-432-7750 or www.Aidance.com

Active Ingredient

Clotrimazole 1%

Principal Display Panel 25g Tube

ALL NATURAL

terrasil

MAX Strength

FOOT & NAIL

ANTI-FUNGAL OINTMENT

with Activated Minerals®


Structured Label Content

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.

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.

Purpose

Antifungal

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

beeswax (organic), cotton seed oil, bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, stearic acid, tea tree oil, zinc oxide.

Section 53413-1 (53413-1)

Questions? 401-432-7750 or www.Aidance.com

Active Ingredient

Clotrimazole 1%

Principal Display Panel 25g Tube (PRINCIPAL DISPLAY PANEL - 25g Tube)

ALL NATURAL

terrasil

MAX Strength

FOOT & NAIL

ANTI-FUNGAL OINTMENT

with Activated Minerals®


Advanced Ingredient Data


Raw Label Data

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