NDC 82385-104 An12 Skin Therapy Vita-b Aloe Soothing Gel

Glycerin

NDC Product Code 82385-104

NDC CODE: 82385-104

Proprietary Name: An12 Skin Therapy Vita-b Aloe Soothing Gel 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: Glycerin 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 product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

  • 82385 - Bestvalue Co., Ltd
    • 82385-104 - An12 Skin Therapy Vita-b Aloe Soothing Gel

NDC 82385-104-01

Package Description: 300 mL in 1 BOTTLE, PUMP

NDC Product Information

An12 Skin Therapy Vita-b Aloe Soothing Gel with NDC 82385-104 is a a human over the counter drug product labeled by Bestvalue Co., Ltd. The generic name of An12 Skin Therapy Vita-b Aloe Soothing Gel is glycerin. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2586849.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

An12 Skin Therapy Vita-b Aloe Soothing Gel 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.


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.

  • ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • ALLANTOIN (UNII: 344S277G0Z)
  • GUAR GUM (UNII: E89I1637KE)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • OREGANO (UNII: 0E5AT8T16U)
  • CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
  • VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ARGININE (UNII: 94ZLA3W45F)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)
  • PULSATILLA KOREANA ROOT (UNII: FY35I16MPL)
  • USNEA BARBATA (UNII: D6DVA9TCAP)
  • WATER (UNII: 059QF0KO0R)

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: Bestvalue Co., Ltd
Labeler Code: 82385
Marketing Category: UNAPPROVED DRUG OTHER - 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: 12-06-2021 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.

An12 Skin Therapy Vita-b Aloe Soothing Gel Product Label Images

An12 Skin Therapy Vita-b Aloe Soothing Gel 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

Glycerin 2%

Purpose

Skin protectant

Uses

It permeates the skin without stickiness and provides rich nutrition to the skin to help skin elasticity, skin sedation, skin moisturization, and prevention of aging.

Warnings

Stop use and consult a specialist If you have symptoms such as red spots, swelling, itching, etc.

Do not use for other than intended purpose

Do not use on areas with scars.

Keep it out of reach of children.

Keep it away from direct sunlight.

Directions

Take out an appropriate amount, spread it evenly on your skin, and tap lightly to absorb it.

Inactive Ingredients

Aloe Barbadensis Leaf Water, Lavandula Angustifolia (Lavender) Water, Propanediol,Chamomilla Recutita (Matricaria) Extract, Water, Zanthoxylum Piperitum Fruit Extract,Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract,Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Vulgare Leaf Extract,Chamaecyparis Obtusa Leaf Extract, Scutellaria Baicalensis Root Extract,Portulaca Oleracea Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment ExtractSaccharomyces/Imperata Cylindrica Root Ferment Extract, Camellia Sinensis Leaf Extract, Carbomer, Arginine, Panthenol,Allantoin, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum

* Please review the disclaimer below.