Undecylenic Acid by Family Dollar Services Inc.
Dosage form: liquid
Ingredients: Undecylenic Acid 25mg in 1.7mL
Labeler: Family Dollar Services Inc.
NDC Code: 55319-055
Antifungal Nail Pen
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.
Undecylenic acid 25%w/w
For the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm)
For relief of:
discomfort which may accompany these conditions
For external use only.
If pregnant or breastfeeding
consult a healthcare professional before use.
Do not use
on children 2 years of age unless directed by a doctor.
When using this product
avoid contact with eyes.
Use only as directed
by a doctor on persons with highly sensitive skin.
Stop use and consult a doctor if
- there is no improvement within 4 weeks
- irritation occurs
Keep out of children.
If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.
Read all warning and directions. Use only as directed.
clean the affected area and dry thoroughly
twist pen base with 3 clicks to saturate brush
apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by the doctor
the brush applicator allows for easy application under nails and surrounding cuticle area
supervise children in the use of this product
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
for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
this product is not effective on the scalp or nails
- store at room temperature 150 - 300C (590 - 860F)
- protect from freezing. if freezing occurs, warm to room temperature.
- keep tightly closed when not in use
Principal Display Panel
Anti- Fungal Nail Pen
Undecylenic Acid 25%
Eliminates Fungus on Fingers, Toes and Around Nails
0.05 FL. OZ (1.7 mL)
- Pre- fikllled with applicator brush
- Covenient and Easy to use
- Dries Quickly
- Non - oily, clean Formula
antifungal pen liquid
|Product Type||HUMAN OTC DRUG||Item Code (Source)||NDC:55319-055
|Route of Administration||TOPICAL||DEA Schedule||
|Active Ingredient/Active Moiety
|Ingredient Name||Basis of Strength||Strength
|Undecylenic Acid (UNDECYLENIC ACID) ||Undecylenic Acid||25 mg in 1.7 mL
|#||Item Code||Package Description
|1||NDC:55319-055-17||1.7 mL in 1 APPLICATOR
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date
|OTC monograph final||part333C||12/15/2017||
|Labeler - Family Dollar Services Inc.
Family Dollar Services Inc.
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