SPL v2
SPL
SPL Set ID d3b12772-43e1-452d-9aa0-65cbd9745484
Route
TOPICAL
Published
Effective Date 2024-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sepia Officinalis Juice (12 [hp_X]) Melaleuca Alternifolia (tea Tree) Leaf Oil (0.04 g)
Inactive Ingredients
Panthenol Water Sodium Chloride Sodium C14-16 Olefin Sulfonate Lauramidopropyl Betaine

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-05-30

Description

SEPIA OFFICINALIS JUICE                   Antifungal treatment melaleuca alternifolia ( Tea                  Antifungal treatment Tree ) Leaf Oil


Medication Information

Description

SEPIA OFFICINALIS JUICE                   Antifungal treatment melaleuca alternifolia ( Tea                  Antifungal treatment Tree ) Leaf Oil

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

● irritation

Section 50565-1

Warnings

For external use only

Ask a doctor before use onchildren under 2 years of age.

When using this productavoid 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.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 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.
Product Label

Inactive Ingredients

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

Active Ingredient                               

SEPIA OFFICINALIS JUICE                   Antifungal treatment

melaleuca alternifolia ( Tea                  Antifungal treatment

Tree ) Leaf Oil


Structured Label Content

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

● irritation

Section 50565-1 (50565-1)

Warnings

For external use only

Ask a doctor before use onchildren under 2 years of age.

When using this productavoid 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.If swallowed, get medical help or contact a Poison Control Center right away.

Directions (DIRECTIONS)
  • Read all package directions and warnings before use.
  • Use only as directed.
  • Clean the affected area with 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.
Product Label (Product label)

Inactive Ingredients

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

Active Ingredient                                (Active ingredient                               )

SEPIA OFFICINALIS JUICE                   Antifungal treatment

melaleuca alternifolia ( Tea                  Antifungal treatment

Tree ) Leaf Oil


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)