CRYSTAL FLUSH MAXIMUM STRENGTH ANTI-FUNGAL FORMULA- undecylenic acid solution

CRYSTAL FLUSH by

Drug Labeling and Warnings

CRYSTAL FLUSH by is a Otc medication manufactured, distributed, or labeled by Triple Point Group, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Undecylenic Acid 25%

Purpose

Anti-fungal

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.

• 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.

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:

• 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.

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).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CRYSTAL FLUSH  MAXIMUM STRENGTH ANTI-FUNGAL FORMULA
undecylenic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80569-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRONELLA OIL (UNII: QYO8Q067D0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
CLOVE OIL (UNII: 578389D6D0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80569-184-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/17/2020

Labeler - Triple Point Group, LLC (058482713)

Registrant - Triple Point Group, LLC (058482713)