CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream

CLOTRIMAZOLE ANTIFUNGAL by

Drug Labeling and Warnings

CLOTRIMAZOLE ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Aru Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Clotrimazole USP 1%

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 the eyes

Stop use and ask a doctor if  irritation occurs  there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

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. (1-800-222-1222)

Directions

• wash the 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 the 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 the scalp or nails

Inactive ingredients

Cetostearyl alcohol, Cetomacrogol 1000, Micro wax, Light liquid paraffin, Paraffin wax, Chlorocresol, Propylene Glycol, Purified water

Other information

Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

 store at temperature not exceeding 30°C (86°F). Do not freeze. See crimp of tube or carton for Lot Number and Expiration Date

Questions or comments?

1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

SPL UNCLASSIFIED SECTION

Cures Most Athlete's Foot

Relieves Itching & Burning, Relieves Cracking and Scaling, Grease less, Non-Staining

Compared to the active ingredient in Lotrimin AF

Distributed by.

ARU PHARMA INC.

MOUNT VERNON, NY 10552

www.qpackrx.com

Packaging

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE ANTIFUNGAL 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70403-925
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PARAFFIN (UNII: I9O0E3H2ZE)
CHLOROCRESOL (UNII: 36W53O7109)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (white to off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70403-925-30	1 in 1 CARTON	01/01/2018
1		30 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	01/01/2018

Labeler - Aru Pharma Inc. (079736192)