NDC 71727-105 Puriface Hydrogel Cleansing Foam

Salicylic Acid

NDC Product Code 71727-105

NDC Code: 71727-105

Proprietary Name: Puriface Hydrogel Cleansing Foam Additional informationCallout TooltipWhat 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: Salicylic Acid Additional informationCallout TooltipWhat 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.


Code Structure
  • 71727 - Imode Korea, Inc.
    • 71727-105 - Puriface Hydrogel Cleansing Foam

NDC 71727-105-02

Package Description: 1 TUBE in 1 BOX > 120 g in 1 TUBE (71727-105-01)

NDC Product Information

Puriface Hydrogel Cleansing Foam with NDC 71727-105 is a a human over the counter drug product labeled by Imode Korea, Inc.. The generic name of Puriface Hydrogel Cleansing Foam is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Imode Korea, Inc.

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 Additional informationCallout TooltipWhat 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.


Puriface Hydrogel Cleansing Foam Active Ingredient(s)

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

  • SALICYLIC ACID .012 g/120g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Imode Korea, Inc.
Labeler Code: 71727
FDA Application Number: part333D Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-08-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Puriface Hydrogel Cleansing Foam Product Label Images

Puriface Hydrogel Cleansing Foam 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 Ingredients

Salicylic acid 0.01%

Purpose

Acne Treatment

Uses

Sebum control

Warnings

Warnings For external use onlyDo not use when skin is red, inflamed, irritated, or painfulWhen using this product§ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.§ avoid contact with eyes. If contact occurs, flush thoroughly with water.Stop use and ask a doctor if§ Rash or irritation on skin develops and lasts Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Wet face. Apply to hands, add water and work into a lather. Gently massage all over face avoiding eye area. Rinse thoroughly and pat dry.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Inactive Ingredients

Water, Stearic Acid, Glycerin, Myristic Acid, Lauric Acid, Potassium Hydroxide, Beeswax, Glyceryl Stearate, Glycol Stearate, Glycol Distearate, Sodium Chloride, Lavandula Angustifolia (Lavender) Oil, Allantoin, Beta-Glucan, Butylene Glycol, Lavandula Angustifolia (Lavender) Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Xanthan Gum, Ceratonia Siliqua (Carob) Gum, Sucrose, Carrageenan, Potassium Chloride, Gellan Gum, Cellulose Gum, Propanediol, Pentylene Glycol, Cocos Nucifera (Coconut) Fruit Extract, Pinus Sylvestris Leaf Extract, Sodium Hyaluronate, 1,2-Hexanediol, Arginine, Disodium EDTA, Citric Acid, Sodium Citrate, Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Hexylene Glycol, Hydroxyacetophenone, Caprylyl Glycol, Ethylhexylglycerin.

* Please review the disclaimer below.

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