CLOTRIMAZOLE (TOPICAL SOLUTION), 1%- clotrimazole solution

Clotrimazole (Topical Solution), 1% by

Drug Labeling and Warnings

Clotrimazole (Topical Solution), 1% by is a Otc medication manufactured, distributed, or labeled by Puro 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 (tinea pedis)
Jock itch (tinea cruris)
Ringworm (tinea corporis)

Effectively relieves
itching  cracking  burning  discomfort which can accompany these conditions.

Warnings

For external use only.

Ask a doctor before use
on children under 2 years of age

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 and 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

This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
clean the affected area and dry thoroughly
apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a 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; change shoes and socks at least once daily.

Other information

store between 15°-30°C (59°-86°F)

Inactive ingredient

polyethylene glycol

Questions or comments?

Call 1-(845) 450-0141
Mon-Fri 9:00AM to 5:00PM EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Lotrimin® AF*

Greaseless, Nonstaining

Not for Ophthalmic use.

Keep this and all medications out of the reach of children.

TAMPER EVIDENT: This bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at the time of purchase.

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

Keep this carton for important information.

Distributed by:
Puro Pharma Inc.
Poughkeepsie, NY 12601

Packaging

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE (TOPICAL SOLUTION), 1% 
clotrimazole solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83474-003
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 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83474-003-34	1 in 1 CARTON	04/15/2024
1		10 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 Drug	M005	04/15/2024

Labeler - Puro Pharma Inc. (128518845)