Crystal Flush Maximum Strength Antifungal Formula

Crystal Flush Maximum Strength Antifungal Formula
SPL v6
SPL
SPL Set ID 1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5
Route
TOPICAL
Published
Effective Date 2020-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (250 mg)
Inactive Ingredients
Citronella Oil Lavender Oil Tea Tree Oil Almond Oil Jojoba Oil Clove Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-17

Description

Undecylenic Acid 25%

Purpose

Anti-fungal


Medication Information

Purpose

Anti-fungal

Description

Undecylenic Acid 25%

Uses:

For cure of most: • ringworm (tinea corporis) • athlete's foot (tinea pedis). For the relief of: • itching• scaling • cracking • burning • redness • soreness • irritation and discomforts which may accompany these conditions. 

Warnings:

For external use only.

Do Not Use

on diaper rash. 

Drug Facts:

Directions:
  • Clean and dry affected area with soap and water and dry throughly.
  • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician.
  • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. For athlete's foot and ringworm. If Conditions persists for longer, consult a physician.
  • Intended for use typically by healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician.
  • This product is not meant to be applied directly to the Scalp or nails.
Package Labeling

Active Ingredient

Undecylenic Acid 25%

Other Ingredients:

Cymbopogan Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).

Ask A Doctor Before Use

on children under two years of age

When Using This Product

avoid contact with eyes.

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within four weeks.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. 

If Pregnant Or Breast Feeding, 

ask a health professional before use.


Structured Label Content

Uses:

For cure of most: • ringworm (tinea corporis) • athlete's foot (tinea pedis). For the relief of: • itching• scaling • cracking • burning • redness • soreness • irritation and discomforts which may accompany these conditions. 

Purpose

Anti-fungal

Warnings:

For external use only.

Do Not Use (DO NOT USE)

on diaper rash. 

Drug Facts: (DRUG FACTS:)

Directions:
  • Clean and dry affected area with soap and water and dry throughly.
  • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician.
  • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. For athlete's foot and ringworm. If Conditions persists for longer, consult a physician.
  • Intended for use typically by healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician.
  • This product is not meant to be applied directly to the Scalp or nails.
Package Labeling

Active Ingredient

Undecylenic Acid 25%

Other Ingredients: (Other ingredients:)

Cymbopogan Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Tocopheryl Acetate (Vitamin E).

Ask A Doctor Before Use (Ask a doctor before use)

on children under two years of age

When Using This Product (When using this product)

avoid contact with eyes.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within four weeks.
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. 

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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