Roota Re V 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 22:34:10

Label at a glance#

ProductRoota Re V Tonic

Active ingredientPANTHENOL

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

panthenol

INACTIVE INGREDIENT SECTION

Aqua (Water), rosa centifolia flower water, sd alcohol 40, butylene glycol, peg-40 hydrogenated castor oil, polysorbate 80, urea, menthol, salicylic acid, methylparaben, , dipotassium glycyrrhizate, hydrolyzed soybean protein, carmellia sinensis leaf extract, , 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, ficus carica fruit extract, morus alba fruit extract, fragrance

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 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
54576-4001-1	2019-11-27	C162847	48780-1	9855d018-ee5b-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54576-4001-1	Roota Re V 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
54576-4001	ROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]	1	Legacy NDC, 1 package rows	20130105_30a75e94-3964-4a42-a6e3-0de6ab290ce5.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
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
FICUS CARICA WHOLE	INACTIVE INGREDIENT	MAW09HMQ3X	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	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
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	1
ROSA CANINA FRUIT OIL	INACTIVE INGREDIENT	CR7307M3QZ	1
ROSA CENTIFOLIA FLOWER	INACTIVE INGREDIENT	CS4TE8FF7O	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	1
SOPHORA FLAVESCENS ROOT	INACTIVE INGREDIENT	IYR6K8KQ5K	1
SOY PROTEIN	INACTIVE INGREDIENT	R44IWB3RN5	1
UREA	INACTIVE INGREDIENT	8W8T17847W	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

Roota Re V Tonic
PANTHENOL
WATER
ALCOHOL
BUTYLENE GLYCOL
POLYOXYL 40 HYDROGENATED CASTOR OIL
POLYSORBATE 80
UREA
MENTHOL
SALICYLIC ACID
ROSA CENTIFOLIA FLOWER
GLYCYRRHIZINATE DIPOTASSIUM
METHYLPARABEN
.ALPHA.-TOCOPHEROL ACETATE
SOY PROTEIN
ALLANTOIN
SODIUM CITRATE
ROSA CANINA FRUIT OIL
EDETATE DISODIUM
FICUS CARICA WHOLE
NIACINAMIDE
PYRIDOXINE HYDROCHLORIDE
SOPHORA FLAVESCENS ROOT
ACORUS CALAMUS ROOT
GINKGO
MORUS ALBA BARK
GLYCYRRHIZA GLABRA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54576-4001	54576-4001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
ROSA CENTIFOLIA FLOWER	CS4TE8FF7O	IACT
GLYCYRRHIZINATE DIPOTASSIUM	CA2Y0FE3FX	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
SOY PROTEIN	R44IWB3RN5	IACT
ALLANTOIN	344S277G0Z	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
ROSA CANINA FRUIT OIL	CR7307M3QZ	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
FICUS CARICA WHOLE	MAW09HMQ3X	IACT
NIACINAMIDE	25X51I8RD4	IACT
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	IACT
SOPHORA FLAVESCENS ROOT	IYR6K8KQ5K	IACT
ACORUS CALAMUS ROOT	XY1K7KIQ0F	IACT
GINKGO	19FUJ2C58T	IACT
MORUS ALBA BARK	7O71A48NDP	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	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 6 · 343 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	SOLUTION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
UREA	UREA	8W8T17847W	TABLET, COATED / ORAL	0.02 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	PASTE, DENTIFRICE / DENTAL	4.7 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVITREAL	0.02 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SOFT TISSUE		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAMUSCULAR	4 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / RECTAL		315 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	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
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 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
85a5ce96-0229-4cff-928e-c422fbb37e0b			30a75e94-3964-4a42-a6e3-0de6ab290ce5	2012-12-31	Warnings	Exact identifier spl id: 85a5ce96-0229-4cff-928e-c422fbb37e0b spl set id: 30a75e94-3964-4a42-a6e3-0de6ab290ce5

Reported adverse events (FAERS/openFDA)#

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