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NDC 63187-0501-15 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: 63187-0501-15
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	63187-0501
Product ID	63187-501_37898929-2314-46ad-b6d2-30e411f9e8d1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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 63187-0501-15 (63187050115)

Pricing Information	N/A
NDC Package Code	63187-501-15
Billing NDC	63187050115
Package	1 TUBE in 1 CARTON (63187-501-15) / 15 g in 1 TUBE
Marketing Start Date	2015-02-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba1dc4a4-073f-4f30-bb9c-9ed043700431 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

•: cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
•: for effective relief of
•: itching
•: scaling
•: cracking
•: burning
•: redness
•: soreness
•: irritation
•: discomfort

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 within 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 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

•: To open: unscrew cap, use the pointed end of cap to puncture seal.
•: store between 2°- 30°C (36° - 86°F)
•: see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:

Taro Pharmaceuticals

U.S.A., Inc.

Hawthorne, NY 10532

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 15 g Carton

Cures Most Athlete's Foot

Athlete's Foot

Cream

Clotrimazole Cream USP,1%

Antifungal Cream

Antifungal Cream

NET WT (1/2 oz) 15 g

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE

clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-501(NDC:51672-2002)
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)
polysorbate 60 (UNII: CAL22UVI4M)
water (UNII: 059QF0KO0R)
sorbitan monostearate (UNII: NVZ4I0H58X)

Product Characteristics
Color	WHITE (Smooth)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-501-15	1 in 1 CARTON	02/02/2015
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:63187-501-30	1 in 1 CARTON	02/02/2015
2		30 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	06/01/1995

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(63187-501)

Revised: 4/2022

Document Id: 37898929-2314-46ad-b6d2-30e411f9e8d1

Set id: ba1dc4a4-073f-4f30-bb9c-9ed043700431

Version: 5

Effective Time: 20220401

Search by Drug Name or NDC

NDC 63187-0501-15 Clotrimazole 1 g/100g Details

Clotrimazole 1 g/100g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63187-0501-15 (63187050115)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ba1dc4a4-073f-4f30-bb9c-9ed043700431 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 15 g Carton

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