NDC 50066-062 Asepxia Acne Wipes

Salicylic Acid

NDC Product Information

Asepxia Acne Wipes with NDC 50066-062 is a a human over the counter drug product labeled by Genomma Lab Usa. The generic name of Asepxia Acne Wipes is salicylic acid. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Genomma Lab Usa

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Asepxia Acne Wipes 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.

  • SALICYLIC ACID 176 mg/1

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.

  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
  • 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.
  • 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: Genomma Lab Usa
Labeler Code: 50066
FDA Application Number: part333D 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: 10-18-2019 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.

Asepxia Acne Wipes Product Label Images

Asepxia Acne Wipes 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

Other

Drug Facts

Distributed by: Genomma Lab USA Inc., Houston, TX, 77027.

Active Ingredient

Salicylic acid 2%

Purpose

Acne medication

Use

For the treatment of acne

Warnings

For external use only

When 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. If this occurs, use only one topical acne medication at a time unless directed by a doctor.Avoid contact with eyes.

Otc - Stop Use

Stop use and ask a doctor if skin irritation occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Cleanse face and rinse thoroughly before applying product.Wipe pad over face and neck covering the affected area with a thin layer 1 to 3 times daily.Because excessive drying of skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.Sensitivity test for new user: Apply product sparingly to 1 or 2 small affected areas during the first 3 days. If no discomfort occurs, follow directions stated above.

Other Information

  • Store in a cool, dry placekeep lid tightly closed

Inactive Ingredients

Water, Hamamelis Virginiana Extract, Caprylyl/Capryl Glucoside, Charcoal Powder, Glycerin, Sodium Hydroxide, Phenoxyethanol, Sodium Benzoate, Citric acid, Parfum.

Questions?

Call toll free 1-877-99-GENOM (43666) Monday to Friday, 8am to 6pm, Central time.

* Please review the disclaimer below.