CLOTRIMAZOLE by Delsam Pharma Llc CLOTRIMAZOLE cream

CLOTRIMAZOLE by

Drug Labeling and Warnings

CLOTRIMAZOLE by is a Otc medication manufactured, distributed, or labeled by Delsam Pharma Llc. 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 ring worm) 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?

1-866-826-1306 between 9am and 4 pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

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

Compared to the active ingredient in Lotrimin AF

ANTIFUNGAL

Cures Most Athlete's Foot

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-105
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: 72570-105-30	1 in 1 CARTON	09/25/2018
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	09/25/2018

Labeler - Delsam Pharma Llc (081369679)