Crystal Flush Maximum Strength Anti-fungal Formula

Crystal Flush Maximum Strength Anti-fungal Formula
SPL v1
SPL
SPL Set ID 84f82b4a-3784-4ce0-89f5-7ee7aae2ca58
Route
TOPICAL
Published
Effective Date 2021-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g)
Inactive Ingredients
Citronella Oil Lavender Oil Tea Tree Oil Almond Oil Jojoba Oil Clove Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL 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. 
Section 50565-1

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Warnings:

For external use only.

  • Ask a doctor before use on children under two years of age. DO NOT USE on diaper rash.

When using this product avoid contact with eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within four weeks.

If pregnant or breast-feeding, ask a health professional before use.

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.
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).


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. 
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose

Anti-fungal

Warnings:

For external use only.

  • Ask a doctor before use on children under two years of age. DO NOT USE on diaper rash.

When using this product avoid contact with eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within four weeks.

If pregnant or breast-feeding, ask a health professional before use.

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.
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).


Advanced Ingredient Data


Raw Label Data

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