CRYSTAL FLUSH MAXIMUM STRENGTH ANTI-FUNGAL FORMULA- tolnaftate solution 
Triple Point Group, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CRYSTAL FLUSH Maximum Strength Anti-Fungal Formula

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.

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).

01b LBL_Crystal Flush w-Tolnaftate

CRYSTAL FLUSH  MAXIMUM STRENGTH ANTI-FUNGAL FORMULA
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80569-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80569-101-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/07/2021
Labeler - Triple Point Group, LLC (058482713)
Registrant - Triple Point Group, LLC (058482713)

Revised: 4/2021
Document Id: 77e5b8f8-1264-4df0-8bcb-eb59378b423f
Set id: c0100085-ed24-4e63-9489-e31801fd262e
Version: 2
Effective Time: 20210428
 
Triple Point Group, LLC