Clotrimazole Topical Solution USP 1%

Clotrimazole Topical Solution 1% by

Drug Labeling and Warnings

Clotrimazole Topical Solution 1% by is a Otc medication manufactured, distributed, or labeled by Delsam Pharma Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLOTRIMAZOLE TOPICAL SOLUTION 1%- clotrimazole liquid 
Delsam Pharma Llc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Clotrimazole Topical Solution USP 1%

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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily For athlete's foot and ringworm infections, use daily for 4 weeks if condition persists longer, consult your doctor

Other Information:

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

Retain this carton for future reference

Inactive Ingredient :

Polyethylene Glycol

Questions or Comments?

1-866-826-1306 between 11 am to 4 pm EST,

Monday-Friday (or)

mail to delsamppharma@yahoo.com

*Compare to the active ingredient in Lotrimin® AF

Relieves itching & burning

Greaseless

Non-Staining

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

Distributed by:
DELSAM PHARMA LLC
MAMARONECK NY 10543

Packaging

CLOTRIMAZOLE TOPICAL SOLUTION 1% 
clotrimazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-136
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: 72570-136-30	1 in 1 CARTON	08/23/2022	03/15/2023
1		30 mL in 1 BOTTLE, DROPPER; 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	08/23/2022	03/15/2023

Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023

Document Id: e2289d1b-83a7-428b-942b-5a4761fd644a

34390-5

Set id: 6eaa45db-0dcb-47c9-926b-c98faa702d62

Version: 2

Effective Time: 20230315