CLOTRIMAZOLE by Delsam Pharma Llc CLOTRIMAZOLE solution

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 infections

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. If contact occurs rinse eyes thoroughly with water.
• Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks 

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 to the affected area twice daily (morning and night) or as directed by your 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

if condition persists longer, consult your doctor

Inactive Ingredient:

Polyethylene Glycol

Other Information:

Store at room temperature (68° to 77°F)

Retain this carton for future reference

Questions or Comments?

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

SPL UNCLASSIFIED SECTION

• Relieves itching & burning
• Greaseless
• Non-Staining

*Compare to the active ingredient in Lotrimin®AF

All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin®AF

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-110-30	1 in 1 CARTON	10/25/2018
1		30 mL in 1 BOTTLE, PLASTIC; 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	10/25/2018

Labeler - Delsam Pharma Llc (081369679)