Active Ingredient
Undecylenic acid 25%
Fungiflush Liquid
FDA Label NDC 83311-100
9 label sections · Submitted to the FDA by Simple Promise Pte Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Simple Promise Pte Ltd for the product Fungiflush (NDC 83311-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
• for athlete’s foot around the toes and feet
• relieves itching, burning, cracking, and scaling
Warnings
Warnings
For external use only
Do not use
• on children under 2 years of age
unless directed by a doctor
When using this product
• avoid contact with the eyes
Stop use and ask a doctor if
• irritation occurs
• there is no improvement within 4 weeks
• for athlete’s foot around the toes and feet
• relieves itching, burning, cracking, and scaling
Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center
right away.
Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or
contact a Poison Control Center
right away.
Directions
wash 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 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 • use daily for 4 weeks.
If condition persists longer, consult a
doctor • this product is not effective on
the scalp or nails
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Canola Oil, Eugenia
Caryophyllus (Clove) Flower Oil, Helianthus
Annuus (Sunflower) Seed Oil, Lavandula
Angustifolia (Lavender) Flower Oil, Leptospermum
Scoparium Branch/Leaf Oil, Melaleuca Alternifolia
(Tea Tree) Leaf Oil, Mentha Piperita (Peppermint)
Oil, Olea Europaea (Olive) Fruit Oil, Origanum
Vulgare Leaf Oil, Propolis Extract, Prunus
Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia
Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate
Other Information
• store at 20-25°C (68-77°F) • do not use if printed
safety seal on cap is broken or missing
Immediate Label
* Please review the disclaimer below.
