Label: FLUSH MAXIMUM STRENGTH ANTIFUNGAL FORMULA- undecylenic acid liquid
- NDC Code(s): 80569-084-15
- 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 November 12, 2021
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- DRUG FACTS:
- Active Ingredient
For external use only.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center right away.
- 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:
- Package Labeling
INGREDIENTS AND APPEARANCE
FLUSH MAXIMUM STRENGTH ANTIFUNGAL FORMULA
undecylenic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80569-084 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 250 mg in 1 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:80569-084-15 15 mL in 1 BOTTLE, GLASS; 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)