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NDC 30142-0510-01 Kroger 10 mg/g Details

Kroger 10 mg/g

Kroger is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Kroger Company. 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: 30142-0510-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clotrimazole Topical

Product Information

NDC	30142-0510
Product ID	30142-510_f8f83364-57f4-431f-97d0-5be1b1548ab8
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	Kroger
Proprietary Name Suffix	Jock Itch
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	Kroger Company
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2023-12-31

Package

Package Images

NDC 30142-0510-01 (30142051001)

Pricing Information	N/A
NDC Package Code	30142-510-01
Billing NDC	30142051001
Package	1 TUBE in 1 CARTON (30142-510-01) / 15 g in 1 TUBE
Marketing Start Date	2013-02-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cc536b67-8b0b-4939-b0fb-9a9e4188c4e5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

cures most jock itch
relieves itching, burning, scaling, chafing and discomfort associated with jock itch

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 eyes

Stop use and ask a doctor if

irritation occurs
there is no improvement within 2 weeks

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

Directions

wash 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
use daily for 2 weeks
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails

Other information

To open: unscrew cap, use the pointed end of cap to puncture seal.
store between 20° - 25°C (68° - 77°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?

1-800-632-6900

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

COMPARE TO active

ingredient in

LOTRIMIN® AF †See back panel

NDC 30142-510-01

Kroger®

Jock Itch

Cream

Clotrimazole Cream USP, 1%

Antifungal Cream

Cures Most Jock Itch

Relieves Itching, Burning, Scaling & Chafing

NET WT .5 OZ (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

INGREDIENTS AND APPEARANCE

KROGER JOCK ITCH

clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-510
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)
sorbitan monostearate (UNII: NVZ4I0H58X)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-510-01	1 in 1 CARTON	02/13/2013
1		15 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	08/31/1993

Labeler - Kroger Company (006999528)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(30142-510)

Revised: 12/2021

Document Id: f8f83364-57f4-431f-97d0-5be1b1548ab8

Set id: cc536b67-8b0b-4939-b0fb-9a9e4188c4e5

Version: 4

Effective Time: 20211230

Search by Drug Name or NDC

NDC 30142-0510-01 Kroger 10 mg/g Details

Kroger 10 mg/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 30142-0510-01 (30142051001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL cc536b67-8b0b-4939-b0fb-9a9e4188c4e5 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

INGREDIENTS AND APPEARANCE

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