NDC | 29978-918-60 |
Set ID | edd8da89-0b83-4de6-a166-7451d0084169 |
Category | HUMAN OTC DRUG LABEL |
Packager | Capital Pharmaceutical, LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Clears up most tinea cruris, candida albicans or tinea corporis.
- For effective relief of itching, scaling, cracking, burning, redness, soreness & irritation.
- For discomfort, scaly skin between the toes or burning feet.
- Clears up most tinea cruris, candida albicans or tinea corporis.
- Warning.
- When Using This Product
- Stop Use and Ask a Doctor if.
- Irritation occurs
- There is no improvement within 4 weeks (for athletes foot and ringworm) or within 2 weeks (for jock itch)
- Irritation occurs
- Keep out of reach of children.
- Directions.
- Clean the affected area and dry thoroughly.
- Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product.
- For athlete’s foot and ringworm: use daily for 4 weeks.
- For Candida Albicans use daily for 2 weeks.
- For athletes foot: Pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least one daily.
- If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails
Other Information.
- Store at 15deg –30deg C (59deg-86deg F)
- Lot No and Exp Date: See Crimp of tube.
- Clean the affected area and dry thoroughly.
- Inactive Ingredients.
- Aloe Vera Gel, Ceresin Wax, Dried Aluminum Hydroxide Gel USP (for Coloring), Lanolin USP, Mineral Oil USP, Snow White PET-G USP.
- Question? Comments?
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ALEVAZOL
clotrimazole ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29978-918 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA WHOLE (UNII: KIZ4X2EHYX) CERESIN (UNII: Q1LS2UJO3A) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29978-918-60 1 in 1 CARTON 1 56.7 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 OTC MONOGRAPH FINAL part333C 09/01/2014 Labeler - Capital Pharmaceutical, LLC (831545541)