CRYSTAL FLUSH MAXIMUM STRENGTH ANTI-FUNGAL FORMULA- undecylenic acid 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

Undecylenic Acid 25%

Purpose

Anti-fungal

Uses:

For cure of most: 

For the relief of:

Warnings:

For external use only.

When using this product avoid contact with eyes.

Stop use and ask a doctor if

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

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

Directions:

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).

01b LBL_Crystal Flush_15mL

CRYSTAL FLUSH  MAXIMUM STRENGTH ANTI-FUNGAL FORMULA
undecylenic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80569-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80569-184-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/17/2020
Labeler - Triple Point Group, LLC (058482713)
Registrant - Triple Point Group, LLC (058482713)

Revised: 3/2021
Document Id: 973c3d59-0c3c-40de-a0de-147f0ca6a11f
Set id: 84f82b4a-3784-4ce0-89f5-7ee7aae2ca58
Version: 1
Effective Time: 20210320
 
Triple Point Group, LLC