Search by Drug Name or NDC

NDC 67234-0014-01 PRO-EX 0.01 g/g Details

PRO-EX 0.01 g/g

PRO-EX is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Natureplex, 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: 67234-0014-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	67234-0014
Product ID	67234-014_2af194fd-04d0-4c5b-b387-024a7903c0b1
Associated GPIs	90154020003705
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	PRO-EX
Proprietary Name Suffix	Anti Fungal
Non-Proprietary Name	Clotrimazole
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.01
Active Ingredient Units	g/g
Substance Name	CLOTRIMAZOLE
Labeler Name	Natureplex, 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 67234-0014-01 (67234001401)

Pricing Information	N/A
NDC Package Code	67234-014-01
Billing NDC	67234001401
Package	42 g in 1 TUBE (67234-014-01)
Marketing Start Date	2008-01-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL be06dd85-e342-4f07-b0e4-c49b3f6b3b4b Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 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.

Avoid contact with eyes.

Do not use on children under 2 years of age unless directed by a doctor.

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night)
supervise children in 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 persists longer, consult a doctor
this product is not effective on scalp or nails

Other information

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 42 g Tube Carton

Natureplex™

NATUREPLEX

QUALITY

GUARANTEED

Pro-Ex

clotrimazole cream

NET WT. 1.5 Oz.

(42g)

Principal Display Panel - 42 g Tube Carton

INGREDIENTS AND APPEARANCE

PRO-EX ANTI FUNGAL

clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67234-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)	Clotrimazole	0.01 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE TRISODIUM (UNII: 420IP921MB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67234-014-01	42 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	01/22/2008

Labeler - Natureplex, LLC (062808196)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex, LLC		062808196	manufacture(67234-014)

Revised: 11/2017

Document Id: 2af194fd-04d0-4c5b-b387-024a7903c0b1

Set id: be06dd85-e342-4f07-b0e4-c49b3f6b3b4b

Version: 12

Effective Time: 20171130