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NDC 73509-0040-02 by Selected Repair Vitality .02; 1 g/50mL; g/50mL Details

by Selected Repair Vitality .02; 1 g/50mL; g/50mL

by Selected Repair Vitality is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Garam Of Nature. The primary component is ADENOSINE; NIACINAMIDE.

Product Information

NDC	73509-0040
Product ID	73509-040_152a5bdc-29d7-4891-9be6-37042687845d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	by Selected Repair Vitality
Proprietary Name Suffix	n/a
Non-Proprietary Name	NIACINAMIDE, ADENOSINE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.02; 1
Active Ingredient Units	g/50mL; g/50mL
Substance Name	ADENOSINE; NIACINAMIDE
Labeler Name	Garam Of Nature
Pharmaceutical Class	Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 73509-0040-02 (73509004002)

Pricing Information	N/A
NDC Package Code	73509-040-02
Billing NDC	73509004002
Package	1 CONTAINER in 1 CARTON (73509-040-02) / 50 mL in 1 CONTAINER (73509-040-01)
Marketing Start Date	2021-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e5fc7064-cb21-4ee8-90ac-3931c9dd31b2 Details

ACTIVE INGREDIENTS

NIACINAMIDE 2.0%

ADENOSINE 0.04%

INACTIVE INGREDIENT

Water, Propanediol, Cyclopentasiloxane, Butylene Glycol, Glycerin, Dimethicone, Hippophae Rhamnoides Fruit Extract, 1,2-Hexanediol, Dimethiconol, PEG-10 Dimethicone, Oryza Sativa (Rice) Extract, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Oryza Sativa (Rice) Callus Culture Extract, Neofinetia Falcata Callus Culture Extract, Nelumbo Nucifera Callus Culture Extract, Myrothamnus Flabellifolia Callus Culture Extract, Taraxacum Platycarpum Callus Culture Extract, Illicium Verum (Anise) Fruit Extract, Eugenia Caryophyllus (Clove) Flower Extract,

Sodium Carbomer, Panthenol, Sericin, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Ethylhexylglycerin, Dipotassium Glycyrrhizate, Xanthan Gum, Caprylyl glycol, Fragrance, Disodium EDTA, Ciric Acid, Potassium Sorbate, Centella Asiatica Extract, Sodium Hyaluronate, Portulaca Oleracea Extract, sh-Oligopeptide-1

PURPOSE

Skin Brightening

Anti-wrinkle

WARNINGS

1. When using cosmetics or after use, consult a specialist If there are any abnormal symptoms or side effects of red spots, welling, or itching in the area of use by direct sunlight.

2. Refrain from using the injured part, etc.

3. Care points for storage a) Store away from children b) Store directly away from direct sunlight

KEEP OUT OF REACH OF CHILDREN

Store away from children

Uses

Helps to brighten skin.

Helps to improve wrinkles in the skin.

Directions

Apply the proper amount to your skin and evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BY SELECTED REPAIR VITALITY

niacinamide, adenosine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73509-040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	1.00 g in 50 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.02 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Propanediol (UNII: 5965N8W85T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73509-040-02	1 in 1 CARTON	07/01/2021
1	NDC:73509-040-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/01/2021

Labeler - Garam Of Nature (695640134)

Registrant - Garam Of Nature (695640134)

Name	Address	ID/FEI	Business Operations
Establishment
Garam Of Nature		695640134	manufacture(73509-040)

Revised: 8/2021

Document Id: 152a5bdc-29d7-4891-9be6-37042687845d

Set id: e5fc7064-cb21-4ee8-90ac-3931c9dd31b2

Version: 1

Effective Time: 20210803