Butenafine Hydrochloride Cream 1%

Butenafine Hydrochloride Cream 1%
SPL v3
SPL
SPL Set ID 83830b24-bc94-4764-a6ca-3193abd9de66
Route
TOPICAL
Published
Effective Date 2023-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2018-10-18

Description

Drug Facts

Purpose

Antifungal


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?

Call 1-866-923-4914

Active Ingredient

Butenafine hydrochloride 1%

Other Information
  • TAMPER EVIDENT:DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE
  • store between 20º to 25º C (68º to 77º 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

CVS

Health ®

Compare to the active

ingredient in Lotrimin

Ultra ®Jock Itch*

NDC 69842-989-08

Prescription Strength

Butenafine

Hydrochloride

Cream 1%

ANTIFUNGAL CREAM

Relieves itching, burning & chafing

Clinically Proven

to Cure Most

JOCK ITCH

Contains the Drug: Butenafine Hydrochloride

NET WT 12 g (0.42 OZ)


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?

Call 1-866-923-4914

Active Ingredient (Active ingredient)

Butenafine hydrochloride 1%

Other Information (Other information)
  • TAMPER EVIDENT:DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE
  • store between 20º to 25º C (68º to 77º 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)

CVS

Health ®

Compare to the active

ingredient in Lotrimin

Ultra ®Jock Itch*

NDC 69842-989-08

Prescription Strength

Butenafine

Hydrochloride

Cream 1%

ANTIFUNGAL CREAM

Relieves itching, burning & chafing

Clinically Proven

to Cure Most

JOCK ITCH

Contains the Drug: Butenafine Hydrochloride

NET WT 12 g (0.42 OZ)


Advanced Ingredient Data


Raw Label Data

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