FDA.reportPublic FDA data

NR-11

Manufacturer
DS Healthcare Group Inc. | A.I.G. Technologies Inc.
Effective date
2017-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:41

Label at a glance#

ProductNR-11
Active ingredientALFATRADIOL, MINOXIDIL SULFATE ESTER, FINASTERIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

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 SECTION

Indicated for male pattern balness; for hair-regrowth

OTC - PURPOSE SECTION

for hair-regrowth

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NR11 LabelNR11 LabelNR11 BoxNR11 Box

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FINASTERIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d00474ae-23eb-a8eb-bf56-520e590cc6dbProduct name220170406
0f90664c-9d0e-f046-dc6a-73563cd8347eProduct name220170405
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69188-163-602020-01-31C16284748780-19d75b9d0-8bd5-f424-e053-dadaa90a57ce52799309-5652-5ed7-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69188-163-60NR-1160 g in 1 BOTTLE, SPRAYLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69188-163NR-11 (MINOXIDIL SULFATE, FINASTERIDE, ALFATRADIOL) LIQUID [DS HEALTHCARE GROUP INC.]11 package rows20170622_52799309-5652-5ed7-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69188-16369188-163-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALFATRADIOL3VQ38D63M7ACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CASEIN48268V50D5IACT
LACTOSEJ2B2A4N98GIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
INOSITOL4L6452S749IACT
ACETYLCYSTEINEWYQ7N0BPYCIACT
SODIUM CITRATE1Q73Q2JULRIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
MINOXIDIL SULFATE ESTER2H6K6Y231JACTIB
FINASTERIDE57GNO57U7GACTIB
MYRISTOYL PENTAPEPTIDE-4PMA59A699XIACT
PREZATIDE COPPER6BJQ43T1I9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALCOHOL3K9958V90MIACT
LACTIC ACID33X04XA5ATIACT
PANTHENYL ETHYL ETHERF4WMF8NX3BIACT
N-ACETYLMETHIONINE9J12WX5B6AIACT
RETINOLG2SH0XKK91IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
52799309-5653-5ed7-e054-00144ff88e8852799309-5652-5ed7-e054-00144ff88e882017-06-21WarningsExact identifier
spl id: 52799309-5653-5ed7-e054-00144ff88e88
spl set id: 52799309-5652-5ed7-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.