NDC 71392-080 Spearmint Aromatherapy Mask 27g

Glycerin

NDC Product Code 71392-080

NDC CODE: 71392-080

Proprietary Name: Spearmint Aromatherapy Mask 27g 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

  • 71392 - Aroma Yong

NDC 71392-080-02

Package Description: 6 POUCH in 1 CARTON > 27 g in 1 POUCH (71392-080-01)

NDC Product Information

Spearmint Aromatherapy Mask 27g with NDC 71392-080 is a a human over the counter drug product labeled by Aroma Yong. The generic name of Spearmint Aromatherapy Mask 27g is glycerin. The product's dosage form is patch and is administered via topical form.

Labeler Name: Aroma Yong

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Spearmint Aromatherapy Mask 27g 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.

  • GLYCERIN .27 g/27g

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.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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.
  • 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: Aroma Yong
Labeler Code: 71392
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: 12-03-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Spearmint Aromatherapy Mask 27g Product Label Images

Spearmint Aromatherapy Mask 27g 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

Active ingredients: Glycerin 1.0%

Inactive Ingredient

Inactive ingredients: Aqua/Water, Opuntia Coccinellifera Fruit Extract, Simmondsia Chinensis Seed Oil, Glycerin, Ascophyllum, Nodosum Extract, Hydroxyethylcellulose, Butylene Glycol, Epilobium Angustifolium Flower/Leaf/Stem Extract, Portulaca Oleracea Extract, Citrus Nobilis Peel Oil, Betaine, Tocopherol, Xanthan Gum, Polyglyceryl-3 Methylglucose Distearate, Trehalose, Hippophae Rhamnoides Water, Zanthoxylum Piperitum Fruit Extract, Lonicera Japonica Flower Extract, Illicium Verum Fruit Extract, Lavandula Angustifolia Oil, Dipotassium Glycyrrhizate, Citrus Aurantium Amara Leaf/Twig Oil, Citrus Paradisi Fruit Extract, Scutellaria Baicalensis Root Extract, Allantoin, Sodium Hyaluronate, Disodium Phosphate, Polysorbate 60, Sodium Phosphate, Caprylyl Glycol, Hydrolyzed Collagen, 1,2-Hexanediol, Acetyl Hexapeptide-8, Limonene**, Linalool**, Citral** ** From pure essential oil

Purpose

Purpose: Skin Brightening & firming effect

Warnings

Warnings: 1) Do not use on damaged or irritated skin and skin with dermatitis 2) Do not use immediately after dermatological treatment or cosmetic surgery .3) Do not use in case of allergy to any of the ingredients 4) For external use only. 5) Do not use directly before exposure to the sunlight 6) Discontinue use if signs of irritation or rashes appear and consult with doctor. 7) Avoid direct contact with eyes. 8) Please be careful if you are irritating to adhesive bandages or patches. 9) Store in a cool and dry place, away from direct sunlight and heath (temperature storage 1-30 degrees), keep out of the reach of children.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Uses: Help increase Brightening in the skinJeju Organic Cactusfruit + blended pure essential oil (Made by ARC (RA)Aromatherapist) Skin Irritation Test Completed / Eco friendly100% Cellulose sheet

Directions

Directions: After washing your face, refine your skin texture with a toner. Then place the mask on your face avoiding the areas around eyes and mouth. After 10 to 20 minutes with the mask on, remove the mask and gently pat the remaining active agents on your face until fully absorbed. For the dry or aging skin types: After using the mask, apply plant-based oil or cream for a better result.

* Please review the disclaimer below.