FDA Label for Puvida Fungal Nail Renewal
View Indications, Usage & Precautions
Puvida Fungal Nail Renewal Product Label
The following document was submitted to the FDA by the labeler of this product Jiangxi Hemei Pharmaceutical Co., Ltd. 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.
Active Ingredient
Undecylenic acid 25%
Purpose
Antifungal
Use
Cures most Athlete's Foot (Tinea Pedis)
and Ringworm (Tinea Corporis). Relieves
itching, scaling, cracking, burning,
redness, sorenes, and irritation and
discomfort. Helps prevent most athlete's
foot (dermatophytosis) with daily use.
Warnings
For external use only.
Do Not Use
on children under 2 years
of age unless directed by a doctor.
When Using
avoid contact with eyes.
Stop Use
irritation occurs, there is no improvement
within 4 weeks (for athlete's foot and
ringworm).
Ask Doctor
irritation occurs, there is no improvement
within 4 weeks (for athlete's foot and
ringworm).
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact
a Poison Control Center right away.
Directions
For athlete's foot and ringworm
: use daily for 4 weeks. 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 child
ren in the use of this product. This product
is not effective for the treatment of ringworm
of the scalp or nails. For athlete's
foot: pay special attention to spaces
between the toes, wear well-fitting, ventilated
shoes, and change shoes and
socks at least once daily. To prevent
athlete's foot, apply once or twice daily
(morning and/or night). Apply to skin
around the nail and cuticle.
Other Information
Store at room temperature 15-30℃ (59-86℉)
Inactive Ingredients
water, euphorbia hirta whole, glycerin, hydracrylic acid, pseudolarix amabilis bark, resorcinol.
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