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NDC 54633-0216-15 Fortinia ID 1.5 g/100mL Details

Fortinia ID 1.5 g/100mL

Fortinia ID is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Podiatree Company. The primary component is PHENOL.

Product Information

NDC	54633-0216
Product ID	54633-216_60c88eb7-22ff-4881-e053-2a91aa0a70ce
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Fortinia ID
Proprietary Name Suffix	n/a
Non-Proprietary Name	phenol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.5
Active Ingredient Units	g/100mL
Substance Name	PHENOL
Labeler Name	The Podiatree Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54633-0216-15 (54633021615)

Pricing Information	N/A
NDC Package Code	54633-216-15
Billing NDC	54633021615
Package	14.8 mL in 1 BOTTLE (54633-216-15)
Marketing Start Date	2017-01-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60c88eb7-22fe-4881-e053-2a91aa0a70ce Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Phenol 1.5%

Purpose

First Aid Antiseptic

Uses

First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns

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.

When using this product

Check skin for sensitivity to phenol prior to application
Use caution when applying as this product will stain skin and clothing

KEEP OUT OF REACH OF CHILDREN

Directions

clean the affected area
apply a small amount on the area one to three times daily

Other Information

Store at controlled room temperature

Inactive Ingredients

Acetone, resorcinol, SD alcohol (13%), water

Questions or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not

completely satisfied, please contact us directly for a full refund.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORTINIA ID

phenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54633-216
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ACETONE (UNII: 1364PS73AF)
RESORCINOL (UNII: YUL4LO94HK)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54633-216-15	14.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/03/2017

Labeler - The Podiatree Company (078656000)

Revised: 12/2017

Document Id: 60c88eb7-22ff-4881-e053-2a91aa0a70ce

Set id: 60c88eb7-22fe-4881-e053-2a91aa0a70ce

Version: 2

Effective Time: 20171220