Label: FLEXITOL ANTI FUNGAL- undecylenic acid liquid
- NDC Code(s): 43251-3351-1
- Packager: LaCorium Health International Pty Ltd
- 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 December 20, 2012
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- For external use only
- Extremely flammable
- Keep away from fire or flame
- Avoid smoking during use and until product has dried
- Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away
- Read all directions and warnings before use
- Clean affected area with soap and warm water and dry thoroughly
- Apply a thin layer of Flexitol Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctor
- For Athlete's Foot, pay special attention to the spaces between the 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. If condition persists longer, consult a doctor.
- Persons under 18 years of age or those with sensitive skin should use only as directed by a doctor
- Supervise children in the use of this product
- This product is not effective on the scalp or nails
- Replace cap and tighten after each use
- Other information
- Inactive ingredients
- Comments or questions?
- PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
INGREDIENTS AND APPEARANCE
FLEXITOL ANTI FUNGAL
undecylenic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43251-3351 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 Isopropyl Alcohol (UNII: ND2M416302) Water (UNII: 059QF0KO0R) Urea (UNII: 8W8T17847W) Eucalyptus Oil (UNII: 2R04ONI662) Hypromellose 2906 (4000 MPA.S) (UNII: 5EYA69XGAT) Tea Tree Oil (UNII: VIF565UC2G) .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) Aloe Vera Leaf (UNII: ZY81Z83H0X) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43251-3351-1 1 in 1 CARTON 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 01/03/2009 Labeler - LaCorium Health International Pty Ltd (758651624)