NDC | 71177-005-01, 71177-005-02 |
Set ID | 48850f93-6fc8-7008-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Pulsaderm Llc |
Generic Name | |
Product Class | Arteriolar Vasodilator |
Product Number | |
Application Number | ANDA075598 |
- Nutrastim Hair Regrowth Treatment Topical Solution USP, 5% Unscented Topical Solution For Men Drug Facts Panel
- Active ingredient:
- Purpose
- Warnings
-
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.
- Minoxidil topical solution 5% 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, infected, irritated, or painful.
- You use other medicines on the scalp.
- ASK DOCTOR
-
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 with each person. This product will not work for all men.
- Stop use and call your doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
-
Other information
- Before use see hair loss pictures on side of this box.
- Keep the box, it contains important information.
- Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with the continuous treatment with minoxidil topical solution 5% for men.
- In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss,
- Minoxidil Topical Solution 5% for men provided more hair regrowth than Minoxidil Topical Solution 2%.
- Store at 20° to 25° C (68° to 77° F).
Keep tightly closed.
- Inactive ingredients:
- Questions?
- Nutrastim Hair Regrowth Treatment Topical Solution USP, 5% Unscented Topical Solution For Men Two Month Supply
-
INGREDIENTS AND APPEARANCE
NUTRASTIM HAIR REGROWTH TREATMENT UNSCENTED FOR MEN
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71177-005 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:71177-005-02 2 in 1 CARTON 02/14/2017 1 NDC:71177-005-01 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 ANDA075598 02/14/2017 Labeler - Pulsaderm Llc (080429881) Establishment Name Address ID/FEI Business Operations Chemolee Lab Corporation 809982754 manufacture(71177-005)