NDC 81120-112 Celesty Hyperpigmentation Series Ultra Brightening Gel Cleanser

Salicylic Acid

NDC Product Code 81120-112

NDC CODE: 81120-112

Proprietary Name: Celesty Hyperpigmentation Series Ultra Brightening Gel Cleanser 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: Salicylic Acid 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 on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

NDC Code Structure

  • 81120 - Maba Kozmetik Limited Sirketi

NDC 81120-112-01

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 200 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Celesty Hyperpigmentation Series Ultra Brightening Gel Cleanser with NDC 81120-112 is a a human over the counter drug product labeled by Maba Kozmetik Limited Sirketi. The generic name of Celesty Hyperpigmentation Series Ultra Brightening Gel Cleanser is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Maba Kozmetik Limited Sirketi

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.

Celesty Hyperpigmentation Series Ultra Brightening Gel Cleanser 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 1 g/100mL

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)
  • AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MORUS ALBA BARK (UNII: 7O71A48NDP)
  • ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)

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: Maba Kozmetik Limited Sirketi
Labeler Code: 81120
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: 12-07-2020 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.

Celesty Hyperpigmentation Series Ultra Brightening Gel Cleanser Product Label Images

Celesty Hyperpigmentation Series Ultra Brightening Gel Cleanser 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 : 1%

Purpose

Acne treatment

Use

Helps clean and prevent uneven skin.

Warnings

For external use only. Do not use on damaged or broken skin.When using this product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if skin irritation develops when using this product.

Additional Information

You may experience mild redness, a warm, tingling sensation or flaking (skin exfoliation). These are normal, temporary indications that the formula is working. If effects persist or cause discomfort, limit use to once every 2 to 3 days until skin adjusts, then revert to daily use.Sunburn Alert This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen and limit sun exposure while using this product. Keep away from fire and flame.

Directions

Lightly lather in hands and apply to damp face and neck morning and evening, massaging upward for at least 30 seconds, avoiding the eye area. Reduce to one use per day if any sensitivity develops. Follow with SPF30 cream when used in the morning.

Inactive Ingredients

Water\Aqua\Eau, Ammonium Laureth Sulfate, Glycolic Acid, Cocamidopropyl Betaine, Potassium Hydroxide, Glycerin, Propylene Glycol, Panthenol (Pro Vitamin B5), Sodium Benzoate, Disodium EDTA, Potassium Sorbate, Benzyl Alcohol, Xanthan Gum, Morus Alba Bark Extract, Arctostaphylos Uva Ursi Leaf Extract, Butylene Glycol, Parfum/Fragrance, Vitamin C (Sodium Ascorbyl Phosphate), Ascorbic Acid.

* Please review the disclaimer below.