JOCK ITCH CREAM- butenafine hydrochloride cream

Jock Itch Cream by

Drug Labeling and Warnings

Jock Itch Cream by is a Otc medication manufactured, distributed, or labeled by TARGET CORPORATION, Sun Pharma Canada Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Butenafine Hydrochloride 1%

PURPOSE

Antifungal

Uses

• cures most jock itch
• relieves itching, burning, crackling, and scaling which accompany this condition

Warnings

For external use only

Do not use

• on nails or scalp
• in or near the mouth or the eyes
• for vaginal yeast infections

When using this productdo not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor iftoo much irritation occurs or irration gets worse.

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

Directions

• adults and children 12 years and older:

• use the tip of the cap to break the seal and open the tube
• wash the affected skin with soap and water and dry completely before applying
• apply once a day to affected skin for 2 weeks or as directed by a doctor
  • wash hands after each use

• children under 12 years: ask a doctor

Other Information

• do not use if seal on tube is broken or not visible
• store between 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENT

Benzyl Alcohol, Cetyl Alcohol, Glycerin, Glyceryl Monostearate SE, Polyoxyethylene (23) Cetyl Ether, Propylene Glycol Dicaprylate, Purified Water, Sodium Benzoate, Stearic Acid, Trolamine, White Petrolatum.

Question?

1-800-910-6874

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

Target Corporation.,

Minneapolis, MN 55403

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

Compare to active ingredient in Lotrimin Ultra ®Jock Itch*

Jock Itch

Cream

Butenafine Hydrochloride

Cream 1%

• Prescription strength
• Relieves itching, burning and chafing
• Clinically proven to cure most jock itch
• Contains the drug:

butenafine hydrochloride

up&up TM

NET WT 0.42 oz (12 g)

INGREDIENTS AND APPEARANCE

JOCK ITCH CREAM 
butenafine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-436
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUTENAFINE HYDROCHLORIDE (UNII: R8XA2029ZI) (BUTENAFINE - UNII:91Y494NL0X)	BUTENAFINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
CETETH-23 (UNII: 495CTZ441V)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-436-01	1 in 1 CARTON	11/15/2024
1		12 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA205181	11/15/2024

Labeler - TARGET CORPORATION (006961700)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(11673-436)