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NDC 63187-0559-15 clotrimazole 1 g/100g Details

clotrimazole 1 g/100g

clotrimazole is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is CLOTRIMAZOLE.

MedlinePlus Drug Summary

Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Related Packages: 63187-0559-15
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	63187-0559
Product ID	63187-559_23ecdf5e-6b0c-4408-a07b-3c33f092816a
Associated GPIs	90154020003705
GCN Sequence Number	007361
GCN Sequence Number Description	clotrimazole CREAM (G) 1 % TOPICAL
HIC3	Q5F
HIC3 Description	TOPICAL ANTIFUNGALS
GCN	30370
HICL Sequence Number	004137
HICL Sequence Number Description	CLOTRIMAZOLE
Brand/Generic	Generic
Proprietary Name	clotrimazole
Proprietary Name Suffix	n/a
Non-Proprietary Name	Clotrimazole
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	CLOTRIMAZOLE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0559-15 (63187055915)

Pricing Information	N/A
NDC Package Code	63187-559-15
Billing NDC	63187055915
Package	1 TUBE in 1 CARTON (63187-559-15) / 15 g in 1 TUBE
Marketing Start Date	2022-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eeb241a3-93ee-4b74-8cbb-65713d15e7e0 Details

Active ingredient

Clotrimazole 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 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

•: 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

Other information

•: store at 20°-25°C (68°-77°F)

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions or comments?

1-800-719-9260

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Principal Display Panel

Cures Most Athlete’s Foot

Relieves Itching & Burning

Greaseless, Non-Staining

Compare to Lotrimin® AF active ingredient

Clotrimazole Cream USP, 1%

Antifungal

NET WT 1 OZ (30 g)

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE

clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-559(NDC:45802-434)
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-559-15	1 in 1 CARTON	04/01/2022
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:63187-559-30	1 in 1 CARTON	09/04/2018
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	06/03/2011

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-559) , RELABEL(63187-559)

Revised: 4/2022

Document Id: 23ecdf5e-6b0c-4408-a07b-3c33f092816a

Set id: eeb241a3-93ee-4b74-8cbb-65713d15e7e0

Version: 6

Effective Time: 20220401