Label: PEAK BODY MENS HAIR REGROWTH TREATMENT- minoxidil 5% solution
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Contains inactivated NDC Code(s)
NDC Code(s): 83121-001-01 - Packager: Securemedical, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 29, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
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DO NOT USE
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% 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 or children
- Your scalp is red, inflammed, infected, irritated, or painful
- You use other medicines on your scalp
- ASK DOCTOR
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WHEN USING
When using this product
- Do not apply on other parts of the body
- Avoid contact with eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- Some people have experienced change 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.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
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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 18-49 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 INGREDIENT
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEAK BODY MENS HAIR REGROWTH TREATMENT
minoxidil 5% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83121-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83121-001-01 3 in 1 BOX 11/29/2022 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 11/29/2022 Labeler - Securemedical, Inc. (128241515) Establishment Name Address ID/FEI Business Operations Pure Source, LLC 080354456 manufacture(83121-001)