Label: FORTINIA ID- phenol liquid
- NDC Code(s): 54633-216-15
- Packager: The Podiatree Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated December 20, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
- in eyes
- with bandages
- on large areas of the body
- longer than one week unless directed by a doctor
- stop use and consult a doctor if condition persists
- in case of deep puncture wounds, animal bites, or serious burns, consult a doctor
- if known to be sensitive to any ingredients in this product
Stop use and ask a doctor or pharmacist if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.
- Directions
- Other Information
- Inactive Ingredients
- Questions or Suggestions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FORTINIA ID
phenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54633-216 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 1.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ACETONE (UNII: 1364PS73AF) RESORCINOL (UNII: YUL4LO94HK) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54633-216-15 14.8 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/03/2017 Labeler - The Podiatree Company (078656000)