Butenafine Hydrochloride Cream 1%

Drug Facts

Composition & Product

Active Ingredients

Butenafine (10 mg)

Inactive Ingredients

Benzyl Alcohol Cetyl Alcohol Glycerin Glyceryl Stearate Se Ceteth-23 Propylene Glycol Dicaprylate Water Sodium Benzoate Stearic Acid Trolamine Petrolatum

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

ANDA Active Since 2017-11-16

Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Warnings

For external use only

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

Do Not Use

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

Questions?

1-888-287-1915

Active Ingredient

Butenafine hydrochloride 1%

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 Ingredients

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

Principal Display Panel 12 G Tube Carton

NDC 49035-178-08

equate™

Compare to Lotrimin Ultra ^®Jock Itch Active Ingredient*

CONTAINS THE DRUG:

BUTENAFINE HYDROCHLORIDE

Butenafine Hydrochloride Cream 1%

Antifungal

Clinically Proven To Cure Most Jock Itch

Prescription Strength
Relieves Itching, Burning and Chafing

NET WT

0.42 OZ (12 g)

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Purpose

Antifungal

Warnings

For external use only

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

Do Not Use (Do not use)

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

Questions?

1-888-287-1915

Active Ingredient (Active ingredient)

Butenafine hydrochloride 1%

Other Information (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 Ingredients (Inactive ingredients)

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

Principal Display Panel 12 G Tube Carton (PRINCIPAL DISPLAY PANEL - 12 g Tube Carton)

NDC 49035-178-08

equate™

Compare to Lotrimin Ultra ^®Jock Itch Active Ingredient*

CONTAINS THE DRUG:

BUTENAFINE HYDROCHLORIDE

Butenafine Hydrochloride Cream 1%

Antifungal

Clinically Proven To Cure Most Jock Itch

Prescription Strength
Relieves Itching, Burning and Chafing

NET WT

0.42 OZ (12 g)

Advanced Ingredient Data

[{"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE SE", "unii": "FCZ5MH785I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETETH-23", "unii": "495CTZ441V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL DICAPRYLATE", "unii": "581437HWX2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTENAFINE", "unii": "91Y494NL0X", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "cures most jock itch relieves itching, burning, cracking, and scaling which accompany this condition", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if too much irritation occurs or irritation gets worse", "50567-7": "When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.", "Purpose": "Antifungal", "Warnings": "For external use only", "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", "Do not use": "on nails or scalp in or near the mouth or the eyes for vaginal yeast infections", "Questions?": "1-888-287-1915", "Active ingredient": "Butenafine hydrochloride 1%", "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 ingredients": "Benzyl Alcohol, Cetyl Alcohol, Glycerin, Glyceryl Monostearate SE, Polyoxyethylene (23) Cetyl Ether, Propylene Glycol Dicaprylate, Purified Water, Sodium Benzoate, Stearic Acid, Trolamine, White Petrolatum", "PRINCIPAL DISPLAY PANEL - 12 g Tube Carton": "NDC 49035-178-08 equate™ Compare to Lotrimin Ultra ® Jock Itch Active Ingredient* CONTAINS THE DRUG: BUTENAFINE HYDROCHLORIDE Butenafine Hydrochloride Cream 1% Antifungal Clinically Proven To Cure Most Jock Itch Prescription Strength Relieves Itching, Burning and Chafing NET WT 0.42 OZ (12 g)"}

Butenafine Hydrochloride Cream 1%

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information