NDC 81647-100 Arocell Vita20 Power

Dimethicone

NDC Product Code 81647-100

NDC CODE: 81647-100

Proprietary Name: Arocell Vita20 Power What is the Proprietary Name?
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: Dimethicone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (including urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

NDC Code Structure

  • 81647 - Ficc Co., Ltd.

NDC 81647-100-02

Package Description: 1 CONTAINER in 1 CARTON > 10 g in 1 CONTAINER (81647-100-01)

NDC Product Information

Arocell Vita20 Power with NDC 81647-100 is a a human over the counter drug product labeled by Ficc Co., Ltd.. The generic name of Arocell Vita20 Power is dimethicone. The product's dosage form is stick and is administered via topical form.

Labeler Name: Ficc Co., Ltd.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Arocell Vita20 Power 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.

  • DIMETHICONE .9 g/10g

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.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
  • TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)

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: Ficc Co., Ltd.
Labeler Code: 81647
FDA Application Number: part347 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-01-2021 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.

Arocell Vita20 Power Product Label Images

Arocell Vita20 Power 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

Dimethicone 9.0%

Inactive Ingredients

Ascorbic Acid (20%), Cetyl Ethylhexanoate, Hydrogenated Vegetable Oil, Triethylhexanoin, Paraffin, Phenyl Trimethicone, Polyethylene, Diisostearyl Malate, Olea Europaea (Olive) Fruit Oil, Polymethylsilsesquioxane, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Glycyrrhiza Glabra (Licorice) Root Extract, Silica Silylate, Sorbitan Isostearate, Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Cera Microcristallina (EU), Caprylyl Glycol, Fragrance (Parfum)

Purpose

Skin protectant

Warnings

For external use onlyConsult a specialist if there are abnormal symptoms or side effects such as redness, swelling or itchiness due to direct sunlight during or after use.Avoid using on wounded areas.Keep out of reach of children

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps protect your skin.■ Helps brighten skin tone.

Directions

■ Apply evenly onto areas with uneven pigmentation.■ Replace the cover after use.

Other Information

■ Keep away from direct sunlight.■ The formulation may soften at a temperature of 113°f or higher, but the content is still safe for use.■ Recommend using at night prior to sleep.■ Ascorbic acid (20%) may cause irritation for those with sensitive skin. To prevent possible irritation, apply as the final step of skin care routine.

* Please review the disclaimer below.