Label: CRYSTAL FLUSH MAXIMUM STRENGTH ANTI-FUNGAL FORMULA- undecylenic acid solution
- NDC Code(s): 80569-184-15
- Packager: Triple Point Group, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated March 20, 2021
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- Active Ingredient
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
- 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:
- 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)