FUNGICURE ANTI-FUNGAL WASH- sepia soap

Fungicure by

Drug Labeling and Warnings

Fungicure by is a Homeopathic medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sepia 12x

Purpose

Antifungal treatment

Uses

For the treatment of most

• jock itch (tinea cruris)
• ringworm (tinea corporis)
• athlete's foot (tinea pedis)
• tinea versicolor

For relief of:

• itching
• scaling
• cracking
• burning
• redness
• soreness
• irritation
• discomforts which may accompany these conditions.
  

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use on children under 2 years of age.

WHEN USING

When using this product avoid contact with the eyes.  If contact occurs rinse thoroughly with water.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 2 weeks (4 weeks for ringworm, athlete's foot and tinea versicolor).
  

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

• Read all package directions and warnings before use.
• Use only as directed.
• Clean the affected area with Fungicure Anti-Fungal Wash and warm water, rinse and dry thoroughly.
• For best results, leave on for 1-2 minutes before rinsing and drying.
  
• Use twice daily (morning and night), or as directed by a doctor.
• This product is not effective on scalp or nails.
• For jock itch, use daily for 2 weeks.
• For ringworm, tinea versicolor and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor.
• 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.
• Intended for use by normally healthy adults only.
• Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
• Supervise children in the use of this product.

Other information

You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Lauramidopropyl betaine, panthenol, phospholipid EFA, purified water, sodium chloride, sodium C14 - 16 olefin sulfonate, tea tree oil.

QUESTIONS

Questions?  1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGICURE  ANTI-FUNGAL WASH
sepia soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-2600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
PANTHENOL (UNII: WV9CM0O67Z)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-2600-23	177 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2017

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC.		001207208	manufacture(0295-2600)