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NDC 68016-0035-06 Clotrimazole 10 mg/g Details

Clotrimazole 10 mg/g

Clotrimazole is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Consortium, LLC. 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: 68016-0035-06
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	68016-0035
Product ID	68016-035_5d6ad412-c7ee-445c-b802-3605a98269f9
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	10
Active Ingredient Units	mg/g
Substance Name	CLOTRIMAZOLE
Labeler Name	Chain Drug Consortium, LLC
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 68016-0035-06 (68016003506)

Pricing Information	N/A
NDC Package Code	68016-035-06
Billing NDC	68016003506
Package	1 TUBE in 1 CARTON (68016-035-06) / 28 g in 1 TUBE
Marketing Start Date	2003-09-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a93b192d-e6c2-4024-84f5-241bdcd34f9a Details

Drug Facts

Active ingredient

Clotrimazole, USP 1%

Purpose

Antifungal

Uses

cures most athlete’s foot, jock itch, and ringworm
relieves itching, burning, cracking, scaling, and discomfort

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 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

wash 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, 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 lasts longer, contact a doctor
this product is not effective on the scalp or nails

Other information

Store between 2°-30°C (36°-86°F).
Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN LOTRIMIN® AF*

Clotrimazole Cream, USP 1%

ANTIFUNGAL

Proven Clinically Effective in the Treatment of Most Athlete's Foot

Relieves: Itching ι Burning ι Cracking ι Scaling

NET WT 1 OZ (28g)

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE

clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-035
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg in 1 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)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68016-035-06	1 in 1 CARTON	09/11/2003
1		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	09/11/2003

Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 11/2022

Document Id: 5d6ad412-c7ee-445c-b802-3605a98269f9

Set id: a93b192d-e6c2-4024-84f5-241bdcd34f9a

Version: 9

Effective Time: 20221121