Label: ANTI FUNGAL FOOT AND BODY- sepia officinalis juice,melaleuca alternifolia liquid
- NDC Code(s): 83004-011-01
- Packager: Rida LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 5, 2024
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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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.
- KEEP OUT OF REACH OF CHILDREN
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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.
- Inactive Ingredients
- Product label
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INGREDIENTS AND APPEARANCE
ANTI FUNGAL FOOT AND BODY
sepia officinalis juice,melaleuca alternifolia liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83004-011 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 TEA TREE OIL (UNII: VIF565UC2G) (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL - UNII:VIF565UC2G) TEA TREE OIL 0.04 g in 1 mL Inactive Ingredients Ingredient Name Strength LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83004-011-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/30/2024 Labeler - Rida LLC (004425803)