FDA.reportPublic FDA data

REVAGAIN Scalp Tonic

Manufacturer
AFFINITY GROUP L.L.C.
Effective date
2015-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:42:30

Label at a glance#

ProductREVAGAIN Scalp Tonic
Active ingredientALLANTOIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

allantoin


INACTIVE INGREDIENT SECTION

water, alcohol, hydrolyzed silk, dimethyl isosorbide, grape seed ext, green tea ext, panthenol, benzyl alcohol, niacinamide, etc.

OTC - PURPOSE SECTION

hair growth and loss prevention


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out or reach of the children


INDICATIONS & USAGE SECTION

spray to the hair loss area of the scalp 1~2 times daily
gently message it throughout the hair loss area for optimal results
do not wash or rinse for at least two hours


WARNINGS SECTION

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this product if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult ypur phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children


DOSAGE & ADMINISTRATION SECTION

for external use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69808-2001-12020-01-31C16284748780-19d75b9d0-9e23-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69808-2001-1REVAGAIN Scalp Tonic60 mL in 1 BOTTLELIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69808-2001REVAGAIN SCALP TONIC (ALLANTOIN) LIQUID [AFFINITY GROUP L.L.C.]1Legacy NDC, 1 package rows20150507_2fda803a-debc-4350-8255-2357308bb927.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0Z1
ALLANTOINACTIVE MOIETY344S277G0Z1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD41
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69808-200169808-2001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZACTIB
WATER059QF0KO0RIACT
PANTHENOLWV9CM0O67ZIACT
NIACINAMIDE25X51I8RD4IACT

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 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
NIACINAMIDENIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4GEL / TOPICAL25 mgExact identifier — unii candidate
4 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4INJECTION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4INJECTION / INTRAMUSCULAR2.5 %w/vExact identifier — unii candidate
4 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4eac257f-ecdc-49e0-8450-0a778b9899f82fda803a-debc-4350-8255-2357308bb9272015-05-07WarningsExact identifier
spl id: 4eac257f-ecdc-49e0-8450-0a778b9899f8
spl set id: 2fda803a-debc-4350-8255-2357308bb927

Reported adverse events (FAERS/openFDA)#

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