NDC 81555-202 Cellandir Scalp Ampoule

Menthol, Salicylic Acid, Allantoin

NDC Product Code 81555-202

NDC 81555-202-01

Package Description: 50 mL in 1 AMPULE

NDC Product Information

Cellandir Scalp Ampoule with NDC 81555-202 is a a human over the counter drug product labeled by H.l.c Group Co., Ltd. The generic name of Cellandir Scalp Ampoule is menthol, salicylic acid, allantoin. The product's dosage form is liquid and is administered via topical form.

Labeler Name: H.l.c Group Co., Ltd

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
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.

Cellandir Scalp Ampoule Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL, UNSPECIFIED FORM .3 mg/100mL
  • SALICYLIC ACID .25 mg/100mL
  • ALLANTOIN .05 mg/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
  • TURMERIC (UNII: 856YO1Z64F)
  • PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)
  • ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)
  • GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
  • GINGER (UNII: C5529G5JPQ)
  • SAFFLOWER (UNII: 4VBL71TY4Y)
  • ACORUS GRAMINEUS ROOT (UNII: Z60N6Q6E19)
  • ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
  • CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
  • REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALCOHOL (UNII: 3K9958V90M)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • ROSEMARY (UNII: IJ67X351P9)
  • BIOTIN (UNII: 6SO6U10H04)
  • C12-14 PARETH-12 (UNII: M0LJS773XW)
  • SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
  • REISHI (UNII: TKD8LH0X2Z)
  • TREHALOSE (UNII: B8WCK70T7I)
  • SWERTIA JAPONICA WHOLE FLOWERING (UNII: 01X0P6GX6C)
  • ANGELICA GIGAS ROOT (UNII: 32766B2FHX)
  • GINKGO (UNII: 19FUJ2C58T)
  • HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
  • ARGININE (UNII: 94ZLA3W45F)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PERSIMMON (UNII: 4V023DD7KL)
  • CAROB (UNII: 5MG5Z946UO)
  • HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
  • REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
  • FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)
  • CHRYSANTHEMUM ZAWADSKII WHOLE (UNII: 8Z1G3DJ591)
  • CHAMOMILE (UNII: FGL3685T2X)
  • SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • FIG (UNII: TGD87RII2U)
  • CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187)
  • CLIMBAZOLE (UNII: 9N42CW7I54)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: H.l.c Group Co., Ltd
Labeler Code: 81555
FDA Application Number: part348 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
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.

Start Marketing Date: 05-06-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Cellandir Scalp Ampoule Product Label Images

Cellandir Scalp Ampoule Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient[S]

Salicylic Acid 0.25%Menthol 0.3%Allantoin 0.05%

Purpose

Dandruff

Use[S]

Cellandir scalp ampoule tonic is a functional product for relieving hair loss symptoms and improving the scalp environment, which efficiently delivers effective ingredients to the scalp.

Warnings

Precautions for Storage and Handling.Keep away from direct sunlight.Wash immediately when it gets into your eyes

Do Not Use

Do not use it in areas with wounds.Do not use it for children under 3 years of age.

Stop Use And Ask A Doctor

Consult a specialist, etc. if there are any abnormal symptoms or side effects, such as red spots, swelling or itching, due to direct sunlight when using or after using cosmetics.

Keep Out Of Reach Of Children

Keep out of reach of children

Directions

After shampooing and drying, apply an appropriate amount on your scalp and pat it with your fingers to massage. It can be used frequently to soothe, moisturize and nourish the irritated scalp.

Inactive Ingredients

Viola Hamiltoniana Extract, Alcohol Denat., Butylene Glycol, C12-14 Pareth-12, 1,2-Hexanediol, r-(Tetrapeptide-38 Hexapeptide-40 Nonapeptide-39 sh-Polypeptide-105), Phosphate Buffered Saline, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Diospyros Kaki Fruit Extract , Camellia Japonica Leaf Extract, Ceratonia Siliqua (Carob) Fruit Extract, Hydroxypropyl Cyclodextrin, Camellia Sinensis Leaf Extract, Swertia Japonica Extract, Curcuma Longa (Turmeric) Root Extract, Angelica Gigas Root Extract, Thuja Orientalis Leaf Extract, Polygonum Multiflorum Root Extract, Eclipta Prostrata Extract , Glycyrrhiza Uralensis (Licorice) Root Extract, Glycine Soja (Soybean) Seed Extract, Forsythia Suspensa Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Schisandra Chinensis Fruit Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Carthamus Tinctorius (Safflower) Flower Extract, Sophora Flavescens Root Extract, Ficus Carica (Fig) Fruit Extract, Chrysanthemum Zawadskii Extract, Cornus Officinalis Fruit Extract, Acorus Gramineus Extract, Artemisia Princeps Leaf Extract, Houttuynia Cordata Extract, Ganoderma Lucidum (Mushroom) Extract, Aspergillus Ferment, Chamomilla Recutita (Matricaria) Flower Extract, Centella Asiatica Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Polygonum Cuspidatum Root Extract, Dipotassium Glycyrrhizate, Methylpropanediol, Menthol, Salicylic Acid, Arginine, Dexpanthenol, Hydroxyethylcellulose , Glyceryl Caprylate, Climbazole, Allantoin, Dipotassium Glycyrrhizate, Trehalose, Biotin, Ethylhexylglycerin, Disodium EDTA

* Please review the disclaimer below.