NDC 81555-203 Seborasershampoo

Salicylic Acid

NDC Product Code 81555-203

NDC CODE: 81555-203

Proprietary Name: Seborasershampoo 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

  • 81555 - H.l.c Group Co., Ltd

NDC 81555-203-01

Package Description: 400 mL in 1 BOTTLE, PUMP

NDC Product Information

Seborasershampoo with NDC 81555-203 is a a human over the counter drug product labeled by H.l.c Group Co., Ltd. The generic name of Seborasershampoo is salicylic acid. The product's dosage form is shampoo and is administered via topical form.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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.

Seborasershampoo 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.


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: H.l.c Group Co., Ltd
Labeler Code: 81555
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: 10-21-2021 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.

Seborasershampoo 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 0.2%

Purpose

Anti dandruff

Use[S]

Hair loss symptom relief shampoo cleanses the scalp of the hair and helps the healthy hair by supplying nutrients as the main ingredient

Warnings

Consult a specialist, etc. if there are any abnormal symptoms or side effects, such as red spots, swelling or itching, due to direct sunlight when using or after using cosmeticsCautions for Storage and HandlingWash the eye immediately when it gets into your eye.Be careful not to wash it with water after use as it may cause hair loss or bleaching

Do Not Use

In areas with wounds, etc.

Keep Out Of Reach Of Children

Keep out of reach of children & Keep it away from direct sunlight

Directions

After fully wetting hair with water, apply an appropriate amount to hair and scalp,Fully lather and wash off with lukewarm water

Inactive Ingredients

WATER, SODIUM C14-16 OLEFIN SULFONATE, LAURAMIDOPROPYL, BETAINE, GLYCERIN, SODIUM CHLORIDE, ALCOHOL DENAT, PROPYLENE GLYCOL LAURATE, R-(TETRAPEPTIDE-38 HEXAPEPTIDE-40 NONAPEPTIDE-39 SH-POLYPEPTIDE-105), METHYLPROPANEDIOL, C12-14 PARETH-12, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, POLYQUATERNIUM-10, PANTHENOL, CLIMBAZOLE, GLYCERYL CAPRYLATE, NIACINAMIDE, BUTYLENE GLYCOL, CITRIC ACID, DISODIUM EDTA, POLYQUATERNIUM-7, 1,2-HEXANEDIOL, PHOSPHATE BUFFERED SALINE, SODIUM BENZOATE, MENTHOL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, CENTELLA ASIATICA EXTRACT, GLYCINE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, POLYGONUM CUSPIDATUM ROOT EXTRACT, SERINE, GLUTAMIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ASPARTIC ACID, LEUCINE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ALANINE, LYSINE, ARGININE, TYROSINE, PHENYLALANINE, VALINE, PROLINE, THREONINE, ISOLEUCINE, HISTIDINE, CYSTEINE, METHIONINE, FRAGRANCE

* Please review the disclaimer below.