Roota Re F for men

Manufacturer: Raphabio Inc | Grace C&T
Effective date: 2012-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:34:10

Label at a glance#

ProductRoota Re F for men

Active ingredientPANTHENOL

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

panthenol

INACTIVE INGREDIENT SECTION

Aqua (Water), Sodium Laureth Sulfate, Cocamide DEA, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betain, Glycerin, Tetrasodium EDTA, Zinc Pyrithion, Sodium Chloride, Glyceryl Distearate, Menthol,Polyquarternium-10, Mentha Piperita (Peppermint) oil, Salicylic Acid,Cetyl Alcohol, Allantoin,Citric Acid,Zinc Sulfate,Disodium EDTA,Rosmarinus Officinalis (Rosemary) Leaf Oil, Pyridoxine HCl,Sophora Angustifolia Root Extract,Acorus Calamus Root Extract ,Polygonum Multiflorum Root Extract, Morus Alba Bark Extract, Glycyrrhiza Glabra (Licorice) Root Extract ,Ginkgo Biloba Leaf Extract, Urea,Niacinamide,Sodium Hydroxide,Copper Tripeptide-1,Methylchloroisothiazolinone, Methylisothiazolinone

OTC - PURPOSE SECTION

hair care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out or reach of the children

INDICATIONS & USAGE SECTION

1. apply sufficient quantity to intended part
2. scrub softly as like doing massage

WARNINGS SECTION

stop use if irritation occurs

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54576-1001-1	2019-11-27	C162847	48780-1	9855d018-e429-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54576-1001-1	Roota Re F for men	240 mL in 1 BOTTLE, WITH APPLICATOR	SHAMPOO	240		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54576-1001	ROOTA RE F FOR MEN (PANTHENOL) SHAMPOO [RAPHABIO INC]	1	Legacy NDC, 1 package rows	20130105_889fb3cb-5a68-483b-aae7-e6e3957821eb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PANTHENOL	ACTIVE INGREDIENT	WV9CM0O67Z	1
PANTHENOL	ACTIVE MOIETY	WV9CM0O67Z	1
ACORUS CALAMUS ROOT	INACTIVE INGREDIENT	XY1K7KIQ0F	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	1
FALLOPIA MULTIFLORA ROOT	INACTIVE INGREDIENT	AUZ3VD75MC	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL DISTEARATE	INACTIVE INGREDIENT	73071MW2KM	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	1
MORUS ALBA BARK	INACTIVE INGREDIENT	7O71A48NDP	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	1
PREZATIDE COPPER	INACTIVE INGREDIENT	6BJQ43T1I9	1
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	1
PYRITHIONE ZINC	INACTIVE INGREDIENT	R953O2RHZ5	1
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	1
SODIUM LAUROYL SARCOSINATE	INACTIVE INGREDIENT	632GS99618	1
SOPHORA FLAVESCENS ROOT	INACTIVE INGREDIENT	IYR6K8KQ5K	1
UREA	INACTIVE INGREDIENT	8W8T17847W	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
ZINC SULFATE	INACTIVE INGREDIENT	89DS0H96TB	1

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

Roota Re F for men
PANTHENOL
WATER
COCO DIETHANOLAMIDE
SODIUM LAUROYL SARCOSINATE
COCAMIDOPROPYL BETAINE
GLYCERIN
EDETATE SODIUM
PYRITHIONE ZINC
SODIUM CHLORIDE
SODIUM LAURETH SULFATE
GLYCERYL DISTEARATE
MENTHOL
PEPPERMINT
SALICYLIC ACID
CETYL ALCOHOL
ALLANTOIN
CITRIC ACID MONOHYDRATE
ZINC SULFATE
EDETATE DISODIUM
ROSEMARY
PYRIDOXINE HYDROCHLORIDE
SOPHORA FLAVESCENS ROOT
ACORUS CALAMUS ROOT
FALLOPIA MULTIFLORA ROOT
MORUS ALBA BARK
GLYCYRRHIZA GLABRA
GINKGO
UREA
NIACINAMIDE
SODIUM HYDROXIDE
PREZATIDE COPPER
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54576-1001	54576-1001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PANTHENOL	WV9CM0O67Z	ACTIB
WATER	059QF0KO0R	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
SODIUM LAUROYL SARCOSINATE	632GS99618	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
GLYCERIN	PDC6A3C0OX	IACT
EDETATE SODIUM	MP1J8420LU	IACT
PYRITHIONE ZINC	R953O2RHZ5	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
GLYCERYL DISTEARATE	73071MW2KM	IACT
MENTHOL	L7T10EIP3A	IACT
PEPPERMINT	V95R5KMY2B	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
CETYL ALCOHOL	936JST6JCN	IACT
ALLANTOIN	344S277G0Z	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
ZINC SULFATE	89DS0H96TB	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ROSEMARY	IJ67X351P9	IACT
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	IACT
SOPHORA FLAVESCENS ROOT	IYR6K8KQ5K	IACT
ACORUS CALAMUS ROOT	XY1K7KIQ0F	IACT
FALLOPIA MULTIFLORA ROOT	AUZ3VD75MC	IACT
MORUS ALBA BARK	7O71A48NDP	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
GINKGO	19FUJ2C58T	IACT
UREA	8W8T17847W	IACT
NIACINAMIDE	25X51I8RD4	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
PREZATIDE COPPER	6BJQ43T1I9	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 11 · 633 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, EXTENDED RELEASE / TRANSDERMAL	0.85 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERYL DISTEARATE	GLYCERYL DISTEARATE	73071MW2KM	TABLET, EXTENDED RELEASE / ORAL		13 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM, AUGMENTED / TOPICAL		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / VAGINAL	0.19 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	AEROSOL, METERED / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GRANULE, FOR SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERYL DISTEARATE	GLYCERYL DISTEARATE	73071MW2KM	CAPSULE, EXTENDED RELEASE / ORAL	39.2 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / RESPIRATORY (INHALATION)	8 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PERINEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	TABLET / ORAL	0.91 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / VAGINAL		20 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, LIQUID FILLED / ORAL	1.5 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	MOUTHWASH / BUCCAL	0.15 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERYL DISTEARATE	GLYCERYL DISTEARATE	73071MW2KM	TABLET / ORAL		100 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / SUBCUTANEOUS		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	CAPSULE / ORAL	1 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e8fe11ac-688d-4443-bcfb-df8122a8d5f4			889fb3cb-5a68-483b-aae7-e6e3957821eb	2012-12-31	Warnings	Exact identifier spl id: e8fe11ac-688d-4443-bcfb-df8122a8d5f4 spl set id: 889fb3cb-5a68-483b-aae7-e6e3957821eb

Reported adverse events (FAERS/openFDA)#

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