HOMEHEALTH ANTIFUNGAL- tolnaftate lotion

HomeHealth Antifungal by

Drug Labeling and Warnings

HomeHealth Antifungal by is a Otc medication manufactured, distributed, or labeled by Home Health, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                           Purpose

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

PURPOSE

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.

WARNINGS

Warnings      For external use only.

INDICATIONS & USAGE

When using this product avoid contact with eyes.

STOP USE

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.

DO NOT USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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.

STORAGE AND HANDLING

Other information      store in a cool, dry place.

INACTIVE INGREDIENT

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.

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

PRINCIPAL DISPLAY PANEL

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOMEHEALTH ANTIFUNGAL 
tolnaftate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76020-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CASTOR OIL (UNII: D5340Y2I9G)
CETYL ALCOHOL (UNII: 936JST6JCN)
GRAPEFRUIT (UNII: O82C39RR8C)
COCOA BUTTER (UNII: 512OYT1CRR)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
LANOLIN (UNII: 7EV65EAW6H)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ROSEMARY OIL (UNII: 8LGU7VM393)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
THYME OIL (UNII: 2UK410MY6B)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76020-100-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/14/2011

Labeler - Home Health (052609675)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(76020-100)