FDA.reportPublic FDA data

FERMODYL

Manufacturer
All Natural Dynamics | Genomma Lab Internacional, S.A.B. de C.V.
Effective date
2019-11-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:01:20

Label at a glance#

ProductFERMODYL Fermo 5
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Pathenol 0.002 mL per 1 mL

Instructions for use:

DOSAGE & ADMINISTRATION SECTION

After washing the hair with Fermo Five Shampoo remove excess water. Distribute the contents of an ampoule at the root of the hair. Gently massage the scalp to facilitate the penetration of the product. DO NOT RINSE and comb as usual.

The best results are achieved by carrying out the complete treatment.

Intensive phase: Apply 1 vial daily for 42 days.

Maintenance phase: Apply one vial every third day for 12 days. If it is necessary to repeat the complete treatment every 6 months.

Precautions:

WARNINGS SECTION

Keep out of reach of children / Not ingestible / Not injected / Avoid contact with eyes, if it happens rinse with plenty of water.

Ingredients:

INACTIVE INGREDIENT SECTION

Water, Alcohol, Humulus lupulus flower extract, Rosmarinus officinalis leaf extract, PEG-60 hydrogenated castor oil, Fragrance, Butylene glycol, Extract of Swertia japonica, Triethanolamine, Silanediol salicylate.

Warning:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out tof reach of children.

Purpose:

OTC - PURPOSE SECTION

SUPPLIES NUTRIENTS TO THE ROOTS, AND MAKES HAIR ELASTIC AND VOLUMINOUS.

Indications:

INDICATIONS & USAGE SECTION

Hair Loss treatment

• Prolong hair’s life

• Doubles the resistance of the hair to the fall

• Increases capillary density by 22%

• Increase the number of hair in growth

phase.

• Promotes thicker, healthier and more vigorous hair growth

Fermodyl 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fermo 5 applicators.Fermo 5 applicators.

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51769-05551769-055-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAINGR
SWERTIA JAPONICA WHOLE FLOWERING01X0P6GX6CINGR
PANTHENOLWV9CM0O67ZINGR
WATER059QF0KO0RINGR
ALCOHOL3K9958V90MINGR
HOPS01G73H6H83INGR
ROSEMARY OIL8LGU7VM393INGR
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGINGR
TROLAMINE9O3K93S3TKINGR
SILANEDIOL SALICYLATEC054DF30K0INGR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9748b83d-b6f6-5ab6-e053-2995a90a526973a5a1f5-ac0d-6991-e053-2991aa0ac3f82019-11-14WarningsExact identifier
spl id: 9748b83d-b6f6-5ab6-e053-2995a90a5269
spl set id: 73a5a1f5-ac0d-6991-e053-2991aa0ac3f8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.