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NDC 71205-0438-05 Major Clotrimazole 10 mg/g Details

Major Clotrimazole 10 mg/g

Major 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: 71205-0438-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	71205-0438
Product ID	71205-438_f70b3add-e332-44cc-86c6-b85164963154
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	Major 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	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 71205-0438-05 (71205043805)

Pricing Information	N/A
NDC Package Code	71205-438-05
Billing NDC	71205043805
Package	1 TUBE in 1 CARTON (71205-438-05) / 14.17 g in 1 TUBE
Marketing Start Date	2020-07-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 93f884c0-76d9-4df4-9eef-b904cfddac49 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Warnings

•: Do not use on children under 2 years of age unless directed by a doctor.
•: For external use only.
•: Avoid contact with eyes.
•: If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

•: Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

•: Clean the affected area and dry thoroughly.
•: Apply a thin layer of this 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 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 conditions persists longer, consult a doctor.
•: This product is not effective on the scalp or nails.

Other information

•: Store at controlled room temperature 15°-30°C (59°-86°F).
•: Close cap tightly after use.

Inactive ingredients

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, Ml 48150 USA

Relabeled By Proficient Rx LP

Thousand Oaks, CA 91320

Re-Oder No. 100431

Principal Display Panel – ½ oz. Tube

NDC 71205-438-05

CLOTRIMAZOLE ANTI-FUNGAL CREAM

CREAM USP, 1%

Cures Most Athlete's Foot NET WT. 14.17 g (1/2oz)

INGREDIENTS AND APPEARANCE

MAJOR CLOTRIMAZOLE

clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-438(NDC:0904-7822)
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
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OCTYLDODECANOL (UNII: 461N1O614Y)
CETYL PALMITATE (UNII: 5ZA2S6B08X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-438-05	1 in 1 CARTON	07/02/2020
1		14.17 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	10/04/2004

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-438) , RELABEL(71205-438)

Revised: 2/2021

Document Id: f70b3add-e332-44cc-86c6-b85164963154

Set id: 93f884c0-76d9-4df4-9eef-b904cfddac49

Version: 2

Effective Time: 20210201