Label: WHITE TETTERINE- miconazole nitrate ointment
- NDC Code(s): 12258-242-01
- Packager: S.S.S. Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 4, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient:
- Purpose:
-
Uses
treats most athlete's foot, jock itch and ringworm. Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch. Relieves itchy, scaly skin between the toes or itching, burning feet associated with athlete's foot
Ask your health professional regarding additional uses
-
Warnings
Do not use on children under 2 years of age unless directed by a doctor
- Do not use on diaper rash
For external use only
-
Directions
Clean the affected area and dry thoroughly. Apply a thin layer of the product over the 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 the spaces between the toes, wear well fitting ventilated shoes, and change shoes and socks at least once daily. For 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 the scalp or nails.
- Other Information
- Other Ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
WHITE TETTERINE
miconazole nitrate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12258-242 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12258-242-01 1 in 1 CARTON 02/28/1995 1 28.4 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 02/28/1995 Labeler - S.S.S. Company (003288321) Establishment Name Address ID/FEI Business Operations S.S.S. Company 003288321 manufacture(12258-242) , pack(12258-242) , label(12258-242)
