NDC | 69842-986-02, 69842-986-03, 69842-986-08 |
Set ID | 5ef3c059-fc25-42da-89c7-b5dab9991795 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS Pharmacy |
Generic Name | |
Product Class | Benzylamine Antifungal |
Product Number | |
Application Number | ANDA205181 |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
- cures most jock itch and ringworm
- relieves itching, burning, cracking, and scaling which accompany these conditions
- Warnings
For external use only
When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
Keep out of reach of children. If swallowed, get medical help or contact a Poison 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
- for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
Apply between and around the toes - for jock itch and ringworm: 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
- adults and children 12 years and older:
- Other information
- 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
Close - Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
CVSHealth™
Butenafine Hydrochloride
Cream 1%Antifungal Cream
Prescription StrengthNET WT 1 OZ (30 g)
Package Contains One Tube - INGREDIENTS AND APPEARANCE
ATHLETES FOOT
butenafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-986 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 benzyl alcohol (UNII: LKG8494WBH) cetyl alcohol (UNII: 936JST6JCN) glycerin (UNII: PDC6A3C0OX) Glyceryl Stearate Se (UNII: FCZ5MH785I) ceteth-23 (UNII: 495CTZ441V) propylene glycol dicaprylate (UNII: 581437HWX2) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) stearic acid (UNII: 4ELV7Z65AP) trolamine (UNII: 9O3K93S3TK) petrolatum (UNII: 4T6H12BN9U) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-986-08 1 in 1 CARTON 11/17/2017 1 12 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69842-986-02 1 in 1 CARTON 11/17/2017 2 30 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69842-986-03 1 in 1 CARTON 11/21/2019 3 30 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 11/17/2017 Labeler - CVS Pharmacy (062312574)