FDA Label for Triple AF
View Indications, Usage & Precautions
Triple AF Product Label
The following document was submitted to the FDA by the labeler of this product Summers Laboratories Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
ACTIVE INGREDIENT
MICONAZOLE NITRATE 2%
Otc - Purpose
PURPOSE
ANTIFUNGAL
Indications & Usage
Uses
- For the treatment of superficial skin infections caused by yeast (Candida albicans).
- Relieves discomfort, irritation, redness and chafing associated with jock itch
- Cures most jock itch (tinea cruris)
Warnings
WARNINGS
FOR EXTERNAL USE ONLY
Otc - When Using
When using this product avoid contact with eyes
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 2 weeks
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.
Dosage & Administration
Directions
- Clean affected area and dry thoroughly
- Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
- Supervise children in the use of this product
- Use daily for 2 weeks; If condition persists longer, consult a doctor
- This product is not effective on the scalp or nails
Inactive Ingredient
Inactive ingredients
White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol, polysorbate 80.
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