Homehealth Antifungal Lotion

Homehealth Antifungal Lotion
SPL v6
SPL
SPL Set ID 895cd24c-3f78-4e2e-bf98-8bb6605798da
Route
TOPICAL
Published
Effective Date 2011-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Almond Oil Aloe Vera Leaf Calendula Officinalis Flower Castor Oil Cetyl Alcohol Grapefruit Cocoa Butter Diazolidinyl Urea Lanolin Lavender Oil Methylparaben Propylene Glycol Propylparaben Rosemary Oil Stearic Acid Tea Tree Oil Thyme Oil Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-02-14

Description

Active Ingredient                                                           Purpose Tolnaftate 1.0%..........................................................Antifungal


Medication Information

Warnings and Precautions

Warnings      For external use only.

Indications and Usage

When using this product avoid contact with eyes.

Dosage and Administration

Directions

- clean the affected area and dry thoroughly; - apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a physician; - 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 jock itch, use daily for 2 weeks. - for athlete's foot and ringworm, use daily for 4 weeks. - if condition persists longer, consult a doctor. - this product is not effective on the scalp or nails.

Description

Antifungal Lotion provides effective relief of itching, scaling, burning, irritation and discomfort associated with athlete's foot, jock itch and ringworm.  The active ingredient, Tolnaftate, combines with a soothing base of natural botanical extracts to yield a truly unique formula.  You can count on Home Health to deliver the natural heath products your family deserves.  No Mineral Oil, No petroleum, No Artificial Colors, No Artificial Fragrance.  Carefully Manufactured for  HomeHealth, Co. Ronkonxoma, NY 11779 U.S.A. 800-445-7137 www.HomeHealthUS.com 2009 Home Health  B11812 03B

Section 44425-7

Other information      store in a cool, dry place.

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch.  Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm.

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor.

Section 51727-6

Inactive Ingredients: Almond oil, aloe vera gel, calendula oil, castor oil, cetyl alcohol, citricidal (grapefruit seed extract), cocoa butter, diazolidinyl urea, lanolin oil, lavender oil, methylparaben, myrrh tincture, propylene glycol, propylparaben, rosemary oil, stearic acid, tea tree oil, thyme oil, triethanolamine, water.

Section 51945-4

HomeHealth  Natural Health Begins at Home  Antifungal Lotion  Tolnaftate  Proven Clinicallyl Effective In the Threatment of Most Athlete's Foot, Jock Itch, Ringworm    Net Wt. 4 fl. oz. (118mL)

Section 55105-1

Uses

- proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm with daily use.  - helps prevent most athlete's foot with daily use.  - for effective relief of itching, burning and cracking.

Section 55106-9

Active Ingredient                                                           Purpose

Tolnaftate 1.0%..........................................................Antifungal


Structured Label Content

Indications and Usage (34067-9)

When using this product avoid contact with eyes.

Dosage and Administration (34068-7)

Directions

- clean the affected area and dry thoroughly; - apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a physician; - 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 jock itch, use daily for 2 weeks. - for athlete's foot and ringworm, use daily for 4 weeks. - if condition persists longer, consult a doctor. - this product is not effective on the scalp or nails.

Warnings and Precautions (34071-1)

Warnings      For external use only.

Description (34089-3)

Antifungal Lotion provides effective relief of itching, scaling, burning, irritation and discomfort associated with athlete's foot, jock itch and ringworm.  The active ingredient, Tolnaftate, combines with a soothing base of natural botanical extracts to yield a truly unique formula.  You can count on Home Health to deliver the natural heath products your family deserves.  No Mineral Oil, No petroleum, No Artificial Colors, No Artificial Fragrance.  Carefully Manufactured for  HomeHealth, Co. Ronkonxoma, NY 11779 U.S.A. 800-445-7137 www.HomeHealthUS.com 2009 Home Health  B11812 03B

Section 44425-7 (44425-7)

Other information      store in a cool, dry place.

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch.  Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients: Almond oil, aloe vera gel, calendula oil, castor oil, cetyl alcohol, citricidal (grapefruit seed extract), cocoa butter, diazolidinyl urea, lanolin oil, lavender oil, methylparaben, myrrh tincture, propylene glycol, propylparaben, rosemary oil, stearic acid, tea tree oil, thyme oil, triethanolamine, water.

Section 51945-4 (51945-4)

HomeHealth  Natural Health Begins at Home  Antifungal Lotion  Tolnaftate  Proven Clinicallyl Effective In the Threatment of Most Athlete's Foot, Jock Itch, Ringworm    Net Wt. 4 fl. oz. (118mL)

Section 55105-1 (55105-1)

Uses

- proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm with daily use.  - helps prevent most athlete's foot with daily use.  - for effective relief of itching, burning and cracking.

Section 55106-9 (55106-9)

Active Ingredient                                                           Purpose

Tolnaftate 1.0%..........................................................Antifungal


Advanced Ingredient Data


Raw Label Data

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