Clotrimazole by Granules Pharmaceuticals Inc. CLOTRIMAZOLE solution

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Granules Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 15º-30ºC (59º-86ºF)

Inactive ingredient

polyethylene glycol

Questions or comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PRINCIPAL DISPLAY PANEL - Container Label

NDC 70010- 229-54

Clotrimazole
(Topical Solution), USP

1%

Antifungal

For External use only,

not for Opthalmic use.

Keep this and all medications out

of the reach of children.

10 mL (1/3 fl oz)

PRINCIPAL DISPLAY PANEL - Container Carton Label

NDC 70010- 229-54

*Compare to the active ingredient in

Lotrimin ® AF

Athlete's Foot Solution

Clotrimazole

(Topical Solution),

USP

1%

Antifungal

Relieves Itching & Burning

Greaseless, Nonstanining

For External use only,

Not for Ophthalmic use.

Keep this and all medications

out of the reach of children.

10 mL (1/3 fl oz)

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70010-229
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70010-229-54	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/22/2023

Labeler - Granules Pharmaceuticals Inc. (079825711)