Target Butenafine Hcl Cream 1%- 12 G

Target Butenafine Hcl Cream 1%- 12 G
SPL v3
SPL
SPL Set ID 1d8a17ae-4e25-f591-e063-6394a90a35dd
Route
TOPICAL
Published
Effective Date 2024-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Butenafine (10 mg)
Inactive Ingredients
Cetyl Alcohol Glycerin Ceteth-23 White Petrolatum Sodium Benzoate Trolamine Propylene Glycol Dicaprylate Glyceryl Stearate Se Benzyl Alcohol Stearic Acid Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2024-11-15

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • cures most jock itch
  • relieves itching, burning, crackling, 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 Poision Control Center right away.

Section 50566-9

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

Section 50567-7

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

Section 51727-6

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

Section 55105-1

Antifungal

Section 55106-9

Butenafine Hydrochloride 1%

Warnings

For external use only

Question?

1-800-910-6874

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


Structured Label Content

Uses
  • cures most jock itch
  • relieves itching, burning, crackling, 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 Poision Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

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

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Butenafine Hydrochloride 1%

Warnings

For external use only

Question?

1-800-910-6874

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
Other Information
  • do not use if seal on tube is broken or not visible
  • store between 20° to 25° C (68° to 77° F)
Principal Display Panel 12 G Tube Carton (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)


Advanced Ingredient Data


Raw Label Data

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