GADADERM ANTIFUNGAL- tolnaftate cream

Gadaderm Antifungal by

Drug Labeling and Warnings

Gadaderm Antifungal by is a Otc medication manufactured, distributed, or labeled by Gadal Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                   Purpose

Tolnaftate 1%                                       Antifungal

PURPOSE

Purpose

Antifungal

INDICATIONS & USAGE

Uses

• Proven clinically to cure most:
• Athlete's foot (tinea pedis)
• Ringworm (tinea corporis)
• Effectively soothes and relieves:
• itching
• burning
• cracking
• Helps prevent most athlete's foot from coming back with daily use.

WARNINGS

Warnings: For External Use Only.

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

• irritation occurs
• There is no improvement within 4 weeks.

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 over the 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 lasts longer, ask a doctor.
• to prevent athlete's foot, apply to the feet once or twice daily (morning and/or night)
• this product is not effective on the scalp or nails

INACTIVE INGREDIENT

Inactive ingredients Mineral oil, propylene glycol, cety stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 cetyl/stearyl ether, methylparaben, sodium m-bisulfite, propylparaben

QUESTIONS

SSS Group LLC.

Miami, Fl 33186

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GADADERM ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-263
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
CETEARETH-6 (UNII: 2RJS3559D3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BISULFITE (UNII: TZX5469Z6I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-263-01	1 in 1 BOX
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2013

Labeler - Gadal Laboratories Inc (841305639)