SIGNATURE CARE ANTIFUNGAL- tolnaftate cream

Signature Care Antifungal by

Drug Labeling and Warnings

Signature Care Antifungal by is a Otc medication manufactured, distributed, or labeled by Better Living Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                      Purpose

Tolnaftate 1%.....................................................Antifungal

PURPOSE

Uses - proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis)

- helps prevent most athlete's foot with daily use - for effective relief of itching, burning and cracking

WARNINGS

For external use only

WHEN USING

When using this product avoid contact with the eyes.

ASK DOCTOR

Stop use and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

DO NOT USE

Do not use on children under 2 years of age except under the advice and supervision of 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

INDICATIONS & USAGE

Directions

- wash affected area and dry thoroughly - apply a thin layer over affected area twice daily (morning and night)

- 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 - use daily for 4 weeks; if condition persists longer, ask a doctor

- to prevent athlete's foot, apply once or twice daily (morning and/or night) - this product is not effective on the scalp

STORAGE AND HANDLING

- store at 20°C to 25°C (68°F to 77°F) - Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients: butylated hydroxytoluene, cetanol, ceteth-20, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

1-888-723-3929

www.livingbetterbrandsLLC.com

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIGNATURE CARE ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-805
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 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETETH-20 (UNII: I835H2IHHX)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-805-15	1 in 1 CARTON	08/26/2015
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/26/2015

Labeler - Better Living Brands LLC (009137209)