Otc - Active Ingredient
MINOXIDIL 5%
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Yifusi Technology Co., Ltd. for the product Carenice 5% Minoxidil Hair Regrowth Treatment (NDC 87086-001). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
MINOXIDIL 5%
Hair regrowth treatment
Use to regrow hair on the top of the scalp(vertex only, see pictures on side carton)
For external use only For use by men only
Extremely Flammable:Avoid fire,flame,or smoking during and immediately following application.
You are a woman
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
Increased hair loss may occur in the early stages of use(2-4 weeks) (activation period of hair follicles), which is anormalohenomenon.
Do not use more than directed.
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.
Effects: Some people may experience dryness and itching of the scalp. In such cases, reduce the dosage or consult a doctor
Chest paint,rapid heartbeat,faintness,or dizziness occurs.
Sudden,unexplained weight gain occurs your hands or fee swell
Scalp irritation or redness occurs.
Unwanted facial hair growth occurs.
Keep out of reach of children.If swallowed, get medical help or contact a Poison ControlCenter right away. (1-800-222-1222)
1:PREP HANDSWITHCOLD WATER
Rinse your fingers in cold water and dry them.
Note: foam will melt oncontact with warmsurfaces.
2:OPEN THE CAP
Hold the bottle with one hand and the lid with the other, then pull it open with force.
3:DISPENSE VERTICALLYONTO A COLD SURFACE
Hold the can straight
upside down. lf you hold the can at an angle, foam may not dispense properly.Press nozzle to dispense half a capful of foam onto cold surface (e.g. dish, or cold hands).
4: APPLY TO SCALPNOT HAIR
Part your hair to expose hair loss area. Massage foam into scalp, not hair.Repeat until all hair loss areas have been covered.
5:CLOSE CAP ANDWASH HANDS
Snap cap back into place.Be sure arrows do not line up, so cap remains child resistant.Wash hands and any surface thoroughly after use.
Inactive ingredients : isobutane, propane, alcohol, butane,glycerin, propyleneglycol, sttearic acid, cetearyl alcohol,polysorbate 20, lactic acid, phenoxyethanol, biota orientalis,leafextract, portulaca oleracea extract, purified water.
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