MedPath

Vitamin C 15 %

Vitamin C 15 Rx Only

Approved
Approval ID

11741b56-0fc4-f0d6-e063-6394a90ae6aa

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 29, 2024

Manufacturers
FDA

PURETEK CORPORATION

DUNS: 785961046

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

L-Ascorbic Acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59088-237
Product Classification
G
Generic Name
L-Ascorbic Acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 29, 2024
FDA Product Classification

INGREDIENTS (31)

BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
DIETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: A1A1I8X02B
Classification: IACT
GINGERInactive
Code: C5529G5JPQ
Classification: IACT
YLANG-YLANG OILInactive
Code: 8YOY78GNNX
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SAFFLOWER OILInactive
Code: 65UEH262IS
Classification: IACT
ASCORBIC ACIDActive
Quantity: 15 mg in 100 mL
Code: PQ6CK8PD0R
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Inactive
Code: WR1WPI7EW8
Classification: IACT
.ALPHA.-TOCOPHEROL, D-Inactive
Code: N9PR3490H9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOMENOLInactive
Code: 24WE03BX2T
Classification: IACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMESInactive
Code: 9S60Q72309
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
PYRIDOXINE HYDROCHLORIDEInactive
Code: 68Y4CF58BV
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM PANTOTHENATEInactive
Code: 568ET80C3D
Classification: IACT
ROSA DAMASCENA FLOWER OILInactive
Code: 18920M3T13
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
LAURETH-23Inactive
Code: N72LMW566G
Classification: IACT
ADZUKI BEANInactive
Code: 31GYU1X0FP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERULIC ACIDInactive
Code: AVM951ZWST
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
SODIUM ASCORBYL PHOSPHATEInactive
Code: 836SJG51DR
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
VETIVER OILInactive
Code: 9M9P32M01L
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/24/2023

Vitamin C Brightening Serum 15%

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free:877-921-7873

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2023

Key Benefits:

• A potent antioxidant that strengthens the skin's natural defenses, brightening the skin and minimizing the effects of previous visible damage.
• Improves the look of wrinkles and fine lines, benefiting the skin.
• Strengthens the skin's defense mechanisms against free radicals and environmental stressors.
• Essential for collagen biosynthesis and has the antiaging effect

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/23/2023

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2023

Safety Information:

• Only for external use.
• Avoid making direct contact with your lips, mouth, nose, or eyes.
• A very small number of users of this product might experience a slight tingling; this should go away with continued use.
• If tingling gets worse, stop using and get medical attention.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2023

Direction:

Step 1: Cleanse the face, then apply 4-5 drops of serum in the morning after cleansing and toning.
Step 2: Wait for the serum to be absorbed into the skin.
Step 3: Apply moisturizer and SPF.

DESCRIPTION SECTION

LOINC: 34089-3Updated: 1/29/2024

Vitamin C Brightening Serum 15%

**Active Ingredient:**L-ascorbic acid 15%

Inactive Ingredients:
Aqua (Purified Water), Bacillus/Cordyceps Sinensis/Ganoderma Lucidum/Inonotus Obliquus/Lentinus Edodes/Phellinus Linteus/Schizophyllum Commune/Tricholoma Matsutake Extract Ferment Filtrate, Butylene Glycol, Cananga Odorata (Ylang Ylang) Flower Oil, GenRx Complex® [consisting of: Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, DL-Alpha Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract], D-alpha Tocopherol, Ethoxydiglycol, Ethylhexylglycerin, Ferulic Acid, Fragrance, Glycerin, Lactobacillus Ferment, Lactobacillus/Centella Asiatica/Gleditsia Sinensis Thorn/Houttuynia Cordata Extract/Phellodendron Amurense Bark/Polygonum Cuspidatum Root/Prunella Vulgaris/Torilis Japonica Extract Ferment Filtrate, Lactobacillus/Rice Ferment Filtrate, Laureth-23, Lavandula Angustifolia (Lavender) Oil, Panthenol, PEG-40 Hydrogenated Castor Oil, Phaseolus Angularis Seed Extract, Phenoxyethanol, Propylene Glycol, Rosa Damascena (Rose) Flower Oil, Saccharomyces/Camellia Sinensis Extract Ferment Filtrate, Vetiveria Zizanoides (Vetiver) Root Oil.

DESCRIPTION

This potent daily antioxidant serum contains 15% L-ascorbic acid, along with a GenRx Complex® to further enhance the serum's effects. It helps protect against free radicals throughout the day, brightens skin tone, and lessens signs of previous skin damage.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 5/23/2023

How Supplied:

Vitamin C Brightening Serum 15% is provided in a 1 fl. oz. (30 mL) bottle with NDC 59088-237-03

Storage:

Keep out of direct sunlight.
** KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.**
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of direct sunlight. Store in a dark, cool place.

This product may undergo a gradual color change to a brown hue as it ages. This change is a natural occurrence and does not affect the product's quality, safety, or effectiveness. The product remains safe for use within its specified shelf life.

Keep cap on tightly.

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Vitamin C 15 % - FDA Drug Approval Details