NDC 81950-001 Salicylic Acid Cotton Sheet

Anti Acne Cotton Tablets

NDC Product Code 81950-001

NDC CODE: 81950-001

Proprietary Name: Salicylic Acid Cotton Sheet 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: Anti Acne Cotton Tablets 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
65 MM
Imprint(s):
NO
Score: 1
Flavor(s):
FRUIT (C73389 - ALCOHOL AND MELON)

NDC Code Structure

  • 81950 - Pang's International Holdings Limited

NDC 81950-001-01

Package Description: 90 TABLET in 1 BOTTLE

NDC Product Information

Salicylic Acid Cotton Sheet with NDC 81950-001 is a a human over the counter drug product labeled by Pang's International Holdings Limited. The generic name of Salicylic Acid Cotton Sheet is anti acne cotton tablets. The product's dosage form is tablet and is administered via topical form.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Salicylic Acid Cotton Sheet 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
  • CISTUS MONSPELIENSIS LEAF (UNII: 1IE70KNO43)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • LAVANDULA STOECHAS WHOLE (UNII: MTZ2ZA34ZV)
  • HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOCETETH-20 (UNII: O020065R7Z)
  • 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: Pang's International Holdings Limited
Labeler Code: 81950
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: 03-30-2020 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.

Salicylic Acid Cotton Sheet Product Label Images

Salicylic Acid Cotton Sheet 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(S)

Salicylic acid 2%...........Acne medication

Purpose

Acne medication

Use

Use for the treatment of acne.

Warnings

Warnings For external use only.

Flammable, keep away from extreme heat or open flame.

Do Not Use

/

Otc - When Using

Avoid contact with eyes.If product gets into eyes, rinse thoroughly with water.

skin irritation and dryness is more likely to occur if you use another topical acne medication at the sametime.lf irritation occurs, onlyy use one topical acne medication at a time.

limit use to the face and neck.
Stop use and ask a doctor if skin or eye irritation develops.Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center immediately.

Otc - Stop Use

Stop use and ask a doctor if skin or eye irritation develops.

Otc - Keep Out Of Reach Of Children

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

Directions

Clean the skin thoroughly before applying this product.

wipe a pad over face and neck to cover the entire affected area with a thin layer one to three times daily.

because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

if bothersome dryness or peeling occur, reduce application to once a day or every other day.

Other Information

Do not flush in toilet.

keep jar lid tightly closed.

store in cool dry place do not freeze.

Inactive Ingredients

Water, alcohol den at., glycerin, isoceteth-20, hydrogenated starch hydrolysate, sodium hydroxide, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, disodium EDTA

Questions

86-0752-2656066

You may also report side effects to this phone number.

* Please review the disclaimer below.