Roota Re F Tonic

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 22:34:11

Label at a glance#

ProductRoota Re F Tonic

Active ingredientPANTHENOL

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

panthenol

INACTIVE INGREDIENT SECTION

Aqua (Water), sd alcohol 40, butylene glycol, peg-40 hydrogenated castor oil, polysorbate 80, urea, menthol, salicylic acid, glycolic acid, dipotassium glycyrrhizate, camphor, tocopheryl acetate, peppermint oil, allantoin, sodium citrate, zinc sulfate, disodium edta, rosemary leaf oil, niacinamide, panax ginseng root extract, pyridoxine hci, sophora angustifolia root extract, acorus calamus root extract, polygonum multiflorum root extract, morus alba bark extract, licorice root extract, ginkgo biloba leaf extract, copper tripeptide-1

OTC - PURPOSE SECTION

hair care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

after shampooing, dry your hair and sclap thoroughly
apply the tonic into scalp and gently massage with fingertips to help absorption

WARNINGS SECTION

stop use if irritation occurs

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1365693	panthenol 0.5 MG in 100 mL Topical Solution	PSN	1
1365693	panthenol 0.005 MG/ML Topical Solution	SCD	1
1365693	panthenol 0.5 MG per 100 ML Topical Solution	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54576-3001-1	2019-11-27	C162847	48780-1	9855d018-e918-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54576-3001-1	Roota Re F Tonic	100 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54576-3001	ROOTA RE F TONIC (PANTHENOL) LIQUID [RAPHABIO INC]	1	Legacy NDC, 1 package rows	20130108_3e00b36f-fe7b-4a17-98aa-6a53b1fadc7c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PANTHENOL	ACTIVE INGREDIENT	WV9CM0O67Z	1
PANTHENOL	ACTIVE MOIETY	WV9CM0O67Z	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ACORUS CALAMUS ROOT	INACTIVE INGREDIENT	XY1K7KIQ0F	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	1
ASIAN GINSENG	INACTIVE INGREDIENT	CUQ3A77YXI	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
FALLOPIA MULTIFLORA ROOT	INACTIVE INGREDIENT	AUZ3VD75MC	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	1
GLYCOLIC ACID	INACTIVE INGREDIENT	0WT12SX38S	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	1
MENTHA PIPERITA	INACTIVE INGREDIENT	79M2M2UDA9	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
MORUS ALBA BARK	INACTIVE INGREDIENT	7O71A48NDP	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	1
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
PREZATIDE COPPER	INACTIVE INGREDIENT	6BJQ43T1I9	1
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	1
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	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 · 30 matching rows.

Roota Re F Tonic
PANTHENOL
WATER
ALCOHOL
BUTYLENE GLYCOL
POLYOXYL 40 HYDROGENATED CASTOR OIL
POLYSORBATE 80
UREA
MENTHOL
SALICYLIC ACID
GLYCOLIC ACID
GLYCYRRHIZINATE DIPOTASSIUM
CAMPHOR (NATURAL)
.ALPHA.-TOCOPHEROL ACETATE
MENTHA PIPERITA
ALLANTOIN
SODIUM CITRATE
ZINC SULFATE
EDETATE DISODIUM
ROSEMARY
NIACINAMIDE
ASIAN GINSENG
PYRIDOXINE HYDROCHLORIDE
SOPHORA FLAVESCENS ROOT
ACORUS CALAMUS ROOT
FALLOPIA MULTIFLORA ROOT
MORUS ALBA BARK
GLYCYRRHIZA GLABRA
GINKGO
PREZATIDE COPPER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54576-3001	54576-3001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PANTHENOL	WV9CM0O67Z	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
UREA	8W8T17847W	IACT
MENTHOL	L7T10EIP3A	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
GLYCOLIC ACID	0WT12SX38S	IACT
GLYCYRRHIZINATE DIPOTASSIUM	CA2Y0FE3FX	IACT
CAMPHOR (NATURAL)	N20HL7Q941	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
MENTHA PIPERITA	79M2M2UDA9	IACT
ALLANTOIN	344S277G0Z	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
ZINC SULFATE	89DS0H96TB	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ROSEMARY	IJ67X351P9	IACT
NIACINAMIDE	25X51I8RD4	IACT
ASIAN GINSENG	CUQ3A77YXI	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
PREZATIDE COPPER	6BJQ43T1I9	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 5 · 265 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRASYNOVIAL	0.2 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	CAPSULE, COATED / ORAL	101.25 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / OPHTHALMIC		26 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / RECTAL		315 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	INJECTION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 4 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / SUBLINGUAL	0.08 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
UREA	UREA	8W8T17847W	CREAM / VAGINAL	0.64 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	MOUTHWASH / BUCCAL	0.15 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	SOLUTION / ORAL		3240 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 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
8262bbb8-27c7-4ee5-ab48-289af41da4a0			3e00b36f-fe7b-4a17-98aa-6a53b1fadc7c	2012-12-31	Warnings	Exact identifier spl id: 8262bbb8-27c7-4ee5-ab48-289af41da4a0 spl set id: 3e00b36f-fe7b-4a17-98aa-6a53b1fadc7c

Reported adverse events (FAERS/openFDA)#

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