OROCHE DERMA REJUVENATOR

Manufacturer
OROCHE
Effective date
2015-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:42:14

Label at a glance#

ProductOROCHE DERMA REJUVENATOR
Active ingredientWitch Hazel
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Hamamelis virginiana(Witch Hazel) Extract 0.01%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: D.I WATER, Galactomyces Ferment Filtrate, Butylene Glycol, Sodium Hyaluronate, Alcohol Denat., Glycerin, Niacinamide, Panthenol, Human Oligopeptide-1, PEG-60 Hydrogenated Castor Oil, rhiza Glabra (Licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Schizandra Chinensis Fruit Extract, Coptis Chinensis Root Extract, Camellia Sinensis Leaf Extract, Asiaticoside, Propolis Wax, 1,2-Hexanediol, Chlorphenesin, Arginine, Carbomer, Sodium Polyacrylate, Adenosine, Fragrance

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. Cautions on storage 1)Keep the cap seal. 2) Keep out of reach of babies and children 3)Do not leave it on high, low temperature or exposed on sunlight.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of babies and children

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications & Usage: Shake it up and down to mix the highly concentrated powder and activated liquid after turning the container upside down and twist it to the right - bust the inner membrance. Press the pump and take appropriate amount, then spread it onto the skin. After that pad the skin lightly for the product to be absorbed well. It is highly recommended to keep this mixed highly concentrated powder and ample in the refrigerator and to be consumed within 30 days.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration: Use the eyedropper to pump 1-2times.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809029192916GTIN-13: 8809029192916
EAN-13: 8809029192916
GTIN storage (14 digits): 08809029192916
oroche derma rejuvenator carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69712-010-012020-01-31C16284748780-19d75b9d0-870d-f424-e053-dadaa90a57ce8ce7b1e4-7ca1-4af5-8c5c-79e565d459d9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69712-010-01OROCHE DERMA REJUVENATOR12 mL in 1 CARTONCREAM122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69712-010OROCHE DERMA REJUVENATOR (WITCH HAZEL) CREAM [OROCHE]2Legacy NDC, 1 package rows20150407_8ce7b1e4-7ca1-4af5-8c5c-79e565d459d9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Witch HazelACTIVE INGREDIENT101I4J0U342
WITCH HAZELACTIVE MOIETY101I4J0U342
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69712-01069712-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Witch Hazel101I4J0U34ACTIB
WATER059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 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
3bde65db-e204-4deb-917e-c78c2d4237ca8ce7b1e4-7ca1-4af5-8c5c-79e565d459d92015-04-07WarningsExact identifier
spl id: 3bde65db-e204-4deb-917e-c78c2d4237ca
spl set id: 8ce7b1e4-7ca1-4af5-8c5c-79e565d459d9

Reported adverse events (FAERS/openFDA)#

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