CRYSTAL FLUSH MAXIMUM STRENGTH ANTI-FUNGAL FORMULA- tolnaftate 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

Tolnaftate 1%

Purpose:

Anti-fungal

Uses:

Effective treatment for athlete's foot (tinea pedis) and ringworm (tinea corporis). For the effective relief of itching, scaling, cracking and discomforts which may accompany these conditions.

Warnings:

For external use only.

• Avoid contact with the eyes.
• Do not use on children under 2 years of age unless directed by a doctor.

• If treating athlete's foot and ringworms: Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks.
• If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children.

Directions:

Clean or wash the affected area and dry throughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by doctor. For athletes foot, pay special attention to space between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. Supervise children in the use of this product.

Inactive ingredients:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CRYSTAL FLUSH  MAXIMUM STRENGTH ANTI-FUNGAL FORMULA
tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80569-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
CITRONELLA OIL (UNII: QYO8Q067D0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
JOJOBA OIL (UNII: 724GKU717M)
CLOVE OIL (UNII: 578389D6D0)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80569-101-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/07/2021

Labeler - Triple Point Group, LLC (058482713)

Registrant - Triple Point Group, LLC (058482713)