ASTONEA CLOTRIMAZOLE 1% ATHLETES FOOT- clotrimazole cream

Astonea Clotrimazole 1% by

Drug Labeling and Warnings

Astonea Clotrimazole 1% by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 1% (w/w)

Purpose

Antifungal

Uses

• cures most athlete's foot, jock itch and ringworm
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

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 eyes.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

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

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 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, ask a doctor
• this product is not effective on the scalp or nails

Other information

• store between 20° - 25°C (68° - 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

Ceteth-20, Cetostearyl Alcohol, Chorocresol, Edetate Disodium, Light Mineral Oil, Propylene Glycol, Sodium Metabisulfite,Water

Principal Display Panel

INGREDIENTS AND APPEARANCE

ASTONEA CLOTRIMAZOLE 1%  ATHLETES FOOT
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
CHLOROCRESOL (UNII: 36W53O7109)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-312-44	28.3 g in 1 TUBE; Type 0: Not a Combination Product	03/04/2020
2	NDC: 77338-312-48	113 g in 1 TUBE; Type 0: Not a Combination Product	03/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/04/2020

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)