NDC | 61715-050-01 |
Set ID | a44c3b24-dae2-4993-a49f-71e4eb63b231 |
Category | HUMAN OTC DRUG LABEL |
Packager | Kinray, Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active Ingredient
- Warnings
- DO NOT USE
Do not use
- on children under 2 years of age unless directed by a doctor.
- for diaper rash
When using this product
- avoid contact with eyes
- STOP USE
Stop use and ask a doctor if
- irritation occurs
- there is no improvementwithin 2 weeks when used for the treatment of jock itch
- there is no improvementwithin 4 weeks when used for athletes foot or ringworm
- Uses
- For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
- Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch or itching burning feet
- Indications and Usage
- Other information.
- Directions
- Clean the affected area and dry thoroughly. Apply a thin layer of cream 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: pay special attention to spaces between toes: wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- Foe athlete's foot and ringworm, use daily for 4 weeks.
- For jock itch, use daily for 2 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on scalp or nails.
- Inactive Ingredients
Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.
Close - Keep Out of Reach of Children
- KEEP OUT OF REACH OF CHILDREN
- If swallowed get medical help or contact a Poison Control Center right away
- PRINCIPAL DISPLAY PANEL
Principal Display Panel
Preferred Plus Pharmacy
Miconazole Nitrate Cream USP 2%
KR Miconazole.jpg
- INGREDIENTS AND APPEARANCE
MICONAZOLE
miconazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-050-01 28.4 g in 1 TUBE; Type 0: Not a Combination Product 03/22/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/21/2013 Labeler - Kinray, Inc. (012574513) Registrant - Dynarex Corporation (008124539)