Tolnaftate by Galentic Pharma (India) Private Limited TOLNAFTATE cream

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

USES

• Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
• Proven effective in the prevention of athlete's foot.
• Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet.

WARNINGS

For external use only

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. 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

If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

• Wash affected area and dry thoroughly
• Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
• 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 athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks. If condition persists longer consult a doctor
• This product is not effective on scalp or nails

OTHER INFORMATION

• Store at 15° to 30°C (59° to 86°F)
• Lot No. & Exp. Date. See box or crimp of tube.

INACTIVE INGREDIENT

Cetyl alcohol, Liquid paraffin, Methylparaben, Polyoxyethylene Cetylether, Propylene Glycol, Propylparaben, Stearyl Alcohol, Sorbitan Monostearate, Purified water.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

Galentic

Tolnaftate

Cream USP, 1%

ANTIFUNGAL

Medicated Cream

Relieves itching and burning

Cures most Athlete's Foot

NET WT.

0.5 OZ. (14g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-014
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
CETYL ALCOHOL (UNII: 936JST6JCN)
CETETH-20 (UNII: I835H2IHHX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-014-12	1 in 1 CARTON	06/01/2012
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 50382-014-13	1 in 1 CARTON	06/15/2019
2		28 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	06/01/2012

Labeler - Galentic Pharma (India) Private Limited (915110464)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	analysis(50382-014) , manufacture(50382-014) , pack(50382-014) , repack(50382-014) , sterilize(50382-014)