FDA.reportPublic FDA data

Sabiway, Hair Re-Growth

Manufacturer
Navarrete Estacio Fernando
Effective date
2016-03-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:07:51

Label at a glance#

ProductSabiway, Hair Re-Growth
Active ingredientROSEMARY
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Rosemary (Rosmarinus officinalis) leaf extract, 1X

OTC - PURPOSE SECTION

Purpose

Hair Re-Growth

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

  • Keep bottle tightly closed and out of reach of childeren, If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Uses

  • Help Hair Re-Growth

WARNINGS SECTION

Warnings

For external use only

  • avoid contact with eyes, if that occures, rinse with plenty of water
  • ask a doctor before use if ou have Psoriasis
  • stop use and ask a doctor if too much scalp irritation or sensitivity develops or increases

DOSAGE & ADMINISTRATION SECTION

Directions

  • Shake well before applying
  • apply onto wet hair
  • provide a gentle massage with teh fingertips
  • rinse with plenty of water

Adults and Childrebn 12 years and older

  • adult apply each day and leave applied 5 minutes
  • start with 1 application daily, then gradually increase 2 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Children under 12 years

  • Children under 12 years, apply each day and leave one minute applied

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Aloe vera (aloe barbadensis extract), ascorbic acid, citric acid, cyanocobalamin, fragrance, methylparaben, olive (olea europaea) oil, potassium chloride, potassium hydroxide, propylparaben, sodium laureth sulfate, sodium lauryl sulfate, tocopherol, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sabiway PDPSabiway PDPSabiway Drug Facts PanelSabiway Drug Facts Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70527-001-012020-01-31C16284748780-19d75b9d0-a3e1-f424-e053-dadaa90a57ce2da62f74-7ed6-6a81-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70527-001-01Sabiway, Hair Re-Growth500 mL in 1 BOTTLESHAMPOO5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70527-001SABIWAY, HAIR RE-GROWTH (ROSEMARY (ROSMARINUS OFFICINALIS) LEAF EXTRACT) SHAMPOO [NAVARRETE ESTACIO FERNANDO]2Legacy NDC, 1 package rows20160506_2da62f74-7ed6-6a81-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70527-00170527-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TOCOPHEROLR0ZB2556P8IACT
METHYLPARABENA2I8C7HI9TIACT
OLIVE OIL6UYK2W1W1EIACT
POTASSIUM CHLORIDE660YQ98I10IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ROSEMARYIJ67X351P9ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CYANOCOBALAMINP6YC3EG204IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
WATER059QF0KO0RIACT

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
322f78b1-3a38-12f4-e054-00144ff8d46c2da62f74-7ed6-6a81-e054-00144ff88e882016-03-09WarningsExact identifier
spl id: 322f78b1-3a38-12f4-e054-00144ff8d46c
spl set id: 2da62f74-7ed6-6a81-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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