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Butenafine hydrochloride 1% - Medication Information

Product NDC Code 69842-989
Drug Name

Butenafine hydrochloride 1%

Type Brand
Pharm Class Benzylamine Antifungal [EPC],
Benzylamines [CS]
Active Ingredients
Butenafine hydrochloride 10 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1298448
Application Number ANDA205181
Labeler Name CVS Pharmacy
Packages
Package NDC Code Description
69842-989-08 1 tube in 1 carton (69842-989-08) / 12 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Butenafine hydrochloride 1%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses cures most jock itch relieves itching, burning, cracking, and scaling which accompany this condition

Purpose

Information about the drug product’s indications for use.
Purpose Antifungal

Spl product data elements

Usually a list of ingredients in a drug product.
Butenafine Hydrochloride 1% Butenafine Hydrochloride Butenafine Hydrochloride Butenafine benzyl alcohol cetyl alcohol glycerin Glyceryl Stearate Se ceteth-23 propylene glycol dicaprylate water sodium benzoate stearic acid trolamine petrolatum

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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) PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on nails or scalp in or near the mouth or the eyes for vaginal yeast infections

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call 1-866-923-4914

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if too much irritation occurs or irritation gets worse

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Storage and handling

Information about safe storage and handling of the drug product.
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)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or irritation gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API