Otc - Active Ingredient
Minoxidil 5.0% w/v
Gettik Hair Regrowth Treatment
FDA Label NDC 71700-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gettik International Llc for the product Gettik Hair Regrowth Treatment (NDC 71700-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hair regrowth treatment for men
Indications & Usage
To regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Warnings
For external use only
For use by men only
Flammable: Keep away from fire or flame
Do not use if
- you are a woman
- your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Solution, 5% is not intended for frontal baldness or receding hairline.
- you have no family history of hair loss
- your hair loss is sudden and/or patchy
- you do not know the reason for your hair loss
- you are under 18 years of age. Do not use on babies and children.
- your scalp is red, inflamed, infected, irritated, or painful
- you use other medicines on the scalp
- do not apply on other parts of the body
- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- some people have experienced changes in hair color and/or texture
- it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
- the amount of hair regrowth is different for each person. This product will not work for all men.
- chest pain, rapid heartbeat, faintness, or dizziness occurs
- sudden, unexplained weight gain occurs
- your hands or feet swell
- scalp irritation or redness occurs
- unwanted facial hair growth occurs
- you do not see hair regrowth in 4 months
Ask a doctor before use if you have heart disease
When using this product
Stop use and ask a doctor if
May be harmful if used when pregnant or breast-feeding
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- apply one ML 2 times a day directly onto the scalp in the hair loss area
- using more or more often will not improve results
- continued use is necessary or hair loss will begin again
Other Safety Information
- see hair loss pictures on side of this carton
- before use read all information on carton and enclosed leaflet
- keep the carton, it contains important information
- hair growth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution 5%
- in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% provided more hair regrowth than Minoxidil Topical Solutions 2%
- store at controlled room temperature 20 degree to 25 degree C (68 degree to 77 degree F)
Inactive Ingredient
alcohol 30% v/v, propylene glycol 50% v/v, purified water
Otc - Questions
Questions: Call your health care professional or Gettik at 1-800-249-8095 or visit our website at https://gettik.com
* Please review the disclaimer below.
