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![REGENPURE PRECISION (MINOXIDIL) LIQUID [SALONCEUTICALS, INC.]](https://medic.hrt.org//dailymed/images/4a113921-b2a9-42cc-e054-00144ff8d46c/Label0.jpg)
| NDC | 71290-813-02 |
| Set ID | 4a113921-b2a9-42cc-e054-00144ff8d46c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Salonceuticals, Inc. |
| Generic Name | |
| Product Class | Arteriolar Vasodilator |
| Product Number | |
| Application Number | ANDA076239 |
- Drug Facts
- ACTIVE INGREDIENT
- Use
-
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. 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 medications 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.KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center right away.
STOP USE AND ASK DOCTOR IF:
• Side effects occur: You may report side effects to FDA at 1-800-FDA-1088 or to Salonceuticals, Inc. at 1-877-706-8688
• Chest pain, rapid heartbeat, faintness, or dizziness occurs.
• Sudden, unexplained weight gain occurs.
• Your hands or feet swell.
• Scalp irritation occurs, and continues or worsens.
• Unwanted facial hair growth occurs. - DIRECTIONS:
-
OTHER INFORMATION:
• See hair loss pictures on side of this carton.
• Before use, read all information on carton and enclosed booklet.
• 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 Minoxidil Topical Solution 5%.
• In clinical studies with mostly white men age 18-45 years with moderate degrees of hair loss, Minoxidil Topical Solution, 5% provided more hair regrowth than Minoxidil Topical Solution, 2%.
• Store at USP controlled room temperature 20° to 25°C (68° to 77°F). - INACTIVE INGREDIENTS:
- QUESTIONS OR COMMENTS?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
REGENPURE PRECISION
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71290-813 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:71290-813-02 1 in 1 BOX 03/05/2017 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 03/04/2017 Labeler - Salonceuticals, Inc. (049002597)
