Label: DYNAREX ANTIFUNGAL POWDER- miconazole powder
- NDC Code(s): 67777-316-01, 67777-316-02
- Packager: Dynarex Corporation
- 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.
Updated November 29, 2022
If you are a consumer or patient please visit this version.
- Active Ingredient
For external use only.
Consult a doctor or pharmacist before using this product if you:
■ Are sensitive to the listed ingredients or any similar medications ■ Are pregnant, planning a pregnancy or breastfeeding
When using this product:
You may occasionally experience some side effects. These are rare and consist of local skin irritation or rashes, which occur if you are unusually sensitive to the ingredients listed.
- Do Not Use
Please read this label carefully before use.
• Dynarex Antifungal Powder is not suitable for the treatment of fungal infections of the scalp or nails, and you should talk to your doctor or pharmacist for alternative treatments for these conditions. In order to ensure successful treatment, it is important to use the powder regularly and to continue for at least 10 days after the disappearance of symptoms. This prevents the infection from reoccurring.
• Remember that most fungal infections are very infectious and can easily be passed on to other family members. In order to prevent this happening, it is important to ensure that anyone who has an infection avoids sharing clothes, towels, or shoes with other family members. After applying the powder, wash and dry your hands thoroughly. If your skin condition does not improve after one week’s use, please consult your doctor or pharmacist.
• If you forget to apply the powder, do not apply the missed dose, but apply the next dose as usual and continue as normal. Do not apply two doses at the same time.
If you are taking oral anticoagulants (drugs used to thin the blood, such as Warfarin), talk to your doctor or pharmacist before use.
Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. In case of accidental ingestion of powder go to the hospital immediately.
- Other information
- Keep Out Of Reach Of Children
- Inactive ingredients
- Principal Display panel
INGREDIENTS AND APPEARANCE
DYNAREX ANTIFUNGAL POWDER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-316 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-316-02 24 in 1 CASE 05/19/2016 1 NDC:67777-316-01 85 g in 1 BOTTLE, PLASTIC; 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 05/19/2016 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539)