84509-008 NDC - PEPTIDE HYALURONIC ACID FACE CREAM (SESAMUM INDICUM (SESAME) SEED EXTRACT,PRUNUS PERSICA (PEACH) RESIN EXTRACT,STERCULIA URENS GUM,TRIPEPTIDE-1,HEXAPEPTIDE-9,ACETYL TETRAPEPTIDE-9,PALMITOYL PENTAPEPTIDE-4,PALMITOYL TETRAPEPTIDE-7,ACETYL HEXAPEPTIDE-8.)

Drug Information

Product NDC: 84509-008
Proprietary Name: Peptide Hyaluronic Acid Face Cream
Non Proprietary Name: Sesamum Indicum (Sesame) Seed Extract,Prunus Persica (Peach) Resin Extract,Sterculia Urens Gum,Tripeptide-1,Hexapeptide-9,Acetyl Tetrapeptide-9,Palmitoyl Pentapeptide-4,Palmitoyl Tetrapeptide-7,Acetyl Hexapeptide-8.
Active Ingredient(s): 600 mg/30g ACETYL HEXAPEPTIDE-8; 600 mg/30g ACETYL TETRAPEPTIDE-9; 600 mg/30g HEXAPEPTIDE-9; 600 mg/30g PALMITOYL PENTAPEPTIDE-4; 600 mg/30g PALMITOYL TETRAPEPTIDE-7; 900 mg/30g PEACH; 600 mg/30g PREZATIDE; 900 mg/30g SESAME SEED; 900 mg/30g STERCULIA URENS WHOLE
Administration Route(s): TOPICAL
Dosage Form(s): CREAM
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Dietary Proteins [CS]; Fruit Proteins [EXT]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	Guangzhou Senmai Biotechnology Co.
Product Type:	HUMAN OTC DRUG
FDA Application Number:	M016
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	8/9/2024

Package Information

No.	Package Code	Package Description	Billing Unit
1	84509-008-01	30 g in 1 BOTTLE (84509-008-01)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	84509-008	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Peptide Hyaluronic Acid Face Cream	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Sesamum Indicum (Sesame) Seed Extract,Prunus Persica (Peach) Resin Extract,Sterculia Urens Gum,Tripeptide-1,Hexapeptide-9,Acetyl Tetrapeptide-9,Palmitoyl Pentapeptide-4,Palmitoyl Tetrapeptide-7,Acetyl Hexapeptide-8.	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	CREAM	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	TOPICAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	8/9/2024	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBER	M016	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	Guangzhou Senmai Biotechnology Co.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACETYL HEXAPEPTIDE-8; ACETYL TETRAPEPTIDE-9; HEXAPEPTIDE-9; PALMITOYL PENTAPEPTIDE-4; PALMITOYL TETRAPEPTIDE-7; PEACH; PREZATIDE; SESAME SEED; STERCULIA URENS WHOLE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	600; 600; 600; 600; 600; 900; 600; 900; 900
ACTIVE INGRED UNIT	mg/30g; mg/30g; mg/30g; mg/30g; mg/30g; mg/30g; mg/30g; mg/30g; mg/30g
PHARM CLASSES	Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]

84509-008 NDC - PEPTIDE HYALURONIC ACID FACE CREAM (SESAMUM INDICUM (SESAME) SEED EXTRACT,PRUNUS PERSICA (PEACH) RESIN EXTRACT,STERCULIA URENS GUM,TRIPEPTIDE-1,HEXAPEPTIDE-9,ACETYL TETRAPEPTIDE-9,PALMITOYL PENTAPEPTIDE-4,PALMITOYL TETRAPEPTIDE-7,ACETYL HEXAPEPTIDE-8.)

Drug Information

Labeler Information

Package Information

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