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5% Minoxidil Hair Growth Foam with Biotin
5% Minoxidil Hair Growth Foam With Biotin Aerosol, Foam
FDA Label NDC 84614-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Ctrip Technology Co., Ltd. for the product 5% Minoxidil Hair Growth Foam With Biotin (NDC 84614-003). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
Otc - Purpose
Hair Regrowih Treaiment
Indications & Usage
Use to regrow hair of the scalp
Warnings
Flammable:keep away from fire or flame.
Keep out of reach of children.
For exlernal use oniy
Otc - Do Not Use
Your hair loss is gudden andlor palchy.
Your hair loss is associald with chidbinth.
You do nol knaw the reason for your hair logs.
You are under 18 years of age. Do not use on babies and children.
Your gcalp is red, intamed, infecled, irritated, or painfu.
You use other medicines on the scalp.
Otc - When Using
Awoid contact with the eyes. in case of accidenlal conlact, rinse eyes withlarge amcunts of cool tap waler.
Some people have experienced changes in hair color andlor lexture.
It takes time lo regrow hair, Resuts may ooour at 3 monihs with twice a dayusage. For some men, you may need to use this product for at least 6 monlhsbefore you see results. The amount of hair regrowih is diferent for eachpergon.
Awoid contact with eyes. in case of aocidenlal contact, rinse eyes with alarge amcunt of cool tap waler.
Otc - Stop Use
Chest pain, rapid hearibeat, aininegs, or dizziness oocurs.
Sudden, unexplained weight gain oocurs.
If umwaneed facil har growth occurs .
lf you do nat see hair regrowth in 6 months.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.lf swalkwed, get medical help or contac a Poison Conlrol Cenler(1-800-222-1222) right away.
Dosage & Administration
1.Shake the bollle, hold it upside down and genlly press the walve to dispensefoam onio your hand, approximalely the size of half a capful
2.Massage the foam inio your gcalp with your fngers, paring your hair intorows to ensure even application to areas with thinning hair. Then, wash yourhands thoroughly.
3.Use Twice Daily and enjoy thicker, fuler hair gronth in as lille as 3 to 6months.
Storage And Handling
Before use, read al informglion on carton and enclosed leale.Store at conlrolled room temperalure 20° lo 25°℃ (68° to 77°F)Do not incinerale container. Do not expose to heat or slore at lemperalureabove 104° F(40°C).
Inactive Ingredient
ALCOHOL
GLYCERIN
CETYL ALCOHOL
STEARYL ALCOHOL
POLYSORBATE 80
ANHYDROUS CITRIC ACID
LACTIC ACID
CASTOR OIL
.ALPHA.-TOCOPHEROL
EDETATE DISODIUM
ISOBUTANE
BUTANE
WATER
Package Label.Principal Display Panel
Label (2)
Label (3)
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