ETADERM MENS MINOXIDIL HAIR REGROWTH TREATMENT EXTRA STRENGTH- minoxidil solution
Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength by
Drug Labeling and Warnings
Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength by is a Otc medication manufactured, distributed, or labeled by NUEPHASE LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Drug Facts
- Active ingredient
- Use
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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. 5% minoxidil topical solution 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, irritated or painful you use other medicines on the scalp
When using this product
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.
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Directions:
prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist apply one mL with spray (6 sprays) 2 times a daydirectly onto the scalp in the hair loss area using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
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Other 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 regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men in clinical studies of mostly white men aged 18-45 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution store at controlled room temperature 20º to 25ºC (68º to 77ºF).
- Inactive Ingredients:
- Questions or comments?
- Package Labeling:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ETADERM MENS MINOXIDIL HAIR REGROWTH TREATMENT EXTRA STRENGTH
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 84180-878 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 84180-878-00 1 in 1 BOX 08/29/2025 1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 08/29/2025 Labeler - NUEPHASE LLC (118900101) Registrant - Pure Source, LLC (080354456)
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