NR-11- minoxidil sulfate, finasteride, alfatradiol liquid

NR-11 by

Drug Labeling and Warnings

NR-11 by is a Otc medication manufactured, distributed, or labeled by DS Healthcare Group Inc., A.I.G. Technologies Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Twice per day, dispense six sprays and massage NR-11 evenly into the
scalp. Do not rinse. For best results, wash hair daily with a high-quality
shampoo. Consult a health-care professional to establish your optimal
treatment regimen.

WARNINGS

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. NOT FOR WOMEN. DO NOT
USE THIS PRODUCT IF YOU HAVE HEART DISEASE OR ARE TAKING BLOOD-PRESSURE-LOWERING
MEDICATIONS. DISCONTINUE USE IMMEDIATELY AND SEE A PHYSICIAN IF YOU EXPERIENCE
CHEST PAIN OR RAPID HEARTBEAT. DO NOT USE IF YOU ARE UNDER 18 YEARS OF AGE. KEEP
OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENT

DEIONIZED WATER, PROPYLENE GLYCOL, ETHYL ALCOHOL, LACTIC ACID, PANTHENYL ETHYL
ETHER, INOSITOL, ACETYL METHIONINE, MILK PROTEIN, SODIUM CITRATE, ACETYL CYSTEINE,
LACTOSE, CITRIC ACID, PHOSPHOLIPIDS, RETINOL, GLYCERIN, POLYSORBATE 80, MYRISTOYL
PENTAPEPTIDE-17, COPPER TRIPEPTIDE-1, PHENOXYETHANOL, CAPRYLYL GLYCOL

INDICATIONS & USAGE

Indicated for male pattern balness; for hair-regrowth

PURPOSE

for hair-regrowth

KEEP OUT OF REACH OF CHILDREN

DO NOT USE IF YOU ARE UNDER 18 YEARS OF AGE. KEEP
OUT OF REACH OF CHILDREN.

ACTIVE INGREDIENT

Minoxidil sulfate ............12%

Finasteride..................... 0.1%

Alfatradiol....................... 0.05%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NR-11 
minoxidil sulfate, finasteride, alfatradiol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69188-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALFATRADIOL (UNII: 3VQ38D63M7) (ALFATRADIOL - UNII:3VQ38D63M7)	ALFATRADIOL	0.05 g  in 100 g
MINOXIDIL SULFATE ESTER (UNII: 2H6K6Y231J) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL SULFATE ESTER	12 g  in 100 g
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)	FINASTERIDE	0.01 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CASEIN (UNII: 48268V50D5)
LACTOSE (UNII: J2B2A4N98G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INOSITOL (UNII: 4L6452S749)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALCOHOL (UNII: 3K9958V90M)
LACTIC ACID (UNII: 33X04XA5AT)
PANTHENYL ETHYL ETHER (UNII: F4WMF8NX3B)
N-ACETYLMETHIONINE (UNII: 9J12WX5B6A)
RETINOL (UNII: G2SH0XKK91)

Product Characteristics
Color	yellow (Light yellow thin liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69188-163-60	60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		06/21/2017

Labeler - DS Healthcare Group Inc. (015504134)

Registrant - DS Healthcare Group Inc. (015504134)

Establishment
Name	Address	ID/FEI	Business Operations
DS Healthcare Group Inc.		015504134	relabel(69188-163)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies Inc.		171837367	manufacture(69188-163)