Label: MENS MINOXIDIL HAIR GROWTH SYSTEM- minoxidil solution
- NDC Code(s): 51326-160-16
- Packager: Topiderm, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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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
- 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 or children
- your scalp is red, inflamed, infected, 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
- Directions
- Inactive Ingredients
- Questions?
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INCMEN'S
Minoxidil Hair RegrowthEXTRA STREGNTH
5% MINOXIDIL
TOPICAL SOLUTION, USP
HAIR REGROWTH TREATMENTReactivates Hair Follicles to Stimulate Regrowth
Clinically Proven to Help Regrow Hair
Topical Solution
UnscentedFor Best Results:
Apply Directly to Scalp. Use Twice DailyOne Month Supply 60mL (2 fl oz)
Available Custom Branded
800.445.2595
c.service@topixpharm.com -
INGREDIENTS AND APPEARANCE
MENS MINOXIDIL HAIR GROWTH SYSTEM
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51326-160 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:51326-160-16 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 03/23/2021 Labeler - Topiderm, Inc. (049121643) Establishment Name Address ID/FEI Business Operations Topix Pharmaceuticals Inc 613171433 PACK(51326-160) Establishment Name Address ID/FEI Business Operations Pure Source, LLC 080354456 MANUFACTURE(51326-160)