NDC 43251-3351 Flexitol Anti Fungal

NDC Product Code 43251-3351

NDC 43251-3351-1

Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Flexitol Anti Fungal with NDC 43251-3351 is a product labeled by Lacorium Health International Pty Ltd. The generic name of Flexitol Anti Fungal is . The product's dosage form is and is administered via form.

Labeler Name: Lacorium Health International Pty Ltd

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Lacorium Health International Pty Ltd
Labeler Code: 43251
Start Marketing Date: 01-03-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Flexitol Anti Fungal Product Label Images

Flexitol Anti Fungal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses

For the treatment of: most Athlete's Foot (Tinea Pedis), Ringworm (Tinea Corporis). For relief of: itching, scaling, cracking, burning, redness, soreness, irritation and discomfort which may accompany these conditions.

Warnings

  • For external use only

Otc - Do Not Use

  • Do not use on children under 2 years of age unless directed by a doctor

Otc - When Using

  • Extremely flammableKeep away from fire or flameAvoid smoking during use and until product has dried

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away

Otc - Stop Use

  • Discontinue use and consult a doctor if irritation occurs or there is no improvement within 4 weeks

Directions

  • Read all directions and warnings before useClean affected area with soap and warm water and dry thoroughlyApply a thin layer of Flexitol Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctorFor 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 doctorSupervise children in the use of this productThis product is not effective on the scalp or nailsReplace cap and tighten after each use

Other Information

Store between 50° – 86°F in a dry place

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Butylated Hydroxytoluebe, Eucalyptus Globulus Oil, Hydroxypropyl Methylcellulose, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol Acetate, Urea, Water

* Please review the disclaimer below.