NDC 80395-203 Spot Care Blue One

Alcohol, Lactic Acid, Salicylic Acid, Benzyl Alcohol, Glycerin

NDC Product Code 80395-203

NDC CODE: 80395-203

Proprietary Name: Spot Care Blue One 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: Alcohol, Lactic Acid, Salicylic Acid, Benzyl Alcohol, Glycerin 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 product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.
  • Drug uses not available

NDC Code Structure

  • 80395 - Leejiham

NDC 80395-203-01

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Spot Care Blue One with NDC 80395-203 is a a human over the counter drug product labeled by Leejiham. The generic name of Spot Care Blue One is alcohol, lactic acid, salicylic acid, benzyl alcohol, glycerin. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Leejiham

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Spot Care Blue One 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.

  • LACTIC ACID .9 g/100mL
  • GLYCERIN .02 g/100mL
  • ALCOHOL 80 mL/100mL
  • BENZYL ALCOHOL .1 g/100mL
  • SALICYLIC ACID .45 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.

  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)
  • BOMBYX MORI LARVA (UNII: 1WYM0QWX33)
  • OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
  • CERAMIDE NP (UNII: 4370DF050B)
  • BEMISIOSE (UNII: 76B4LOB2YC)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • RAFFINOSE (UNII: N5O3QU595M)
  • PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
  • STAR ANISE FRUIT (UNII: CK15HA8438)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
  • PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • BIOTIN (UNII: 6SO6U10H04)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)

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: Leejiham
Labeler Code: 80395
FDA Application Number: part347 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-02-2020 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: 12-31-2021 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.

Spot Care Blue One 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

Alcohol 80%Lactic Acid 0.9%Salicylic Acid 0.45%Glycerin 0.02%Benzyl Alcohol 0.1%

Purpose

Skin ProtectantAcne

Uses

Water type ampule for acne skin caused by excessive sebum and dead skin cells clogging pores.

Directions

After cleansing, soak cotton butt or cotton pad and apply on acnes.

Inactive Ingredients

Alcohol, Water, Lactic Acid, Candida Bombicola/Glucose/Methyl Rapeseedate Ferment, Salicylic Acid, Phytosphingosine, Glycerin, Panthenol, Hydrogenated Lecithin, Niacinamide, Raffinose, Ceramide NP, Cholesterol, Hydrogenated Starch Hydrolysate, Glycosyl Trehalose, Ethylhexylglycerin, Silkworm Extract, Scutellaria Baicalensis Root Extract, Illicium Verum (Anise) Fruit Extract, 1,2-Hexanediol, PEG-60 Almond Glycerides, Caprylyl Glycol, Carbomer, Butylene Glycol, Nordihydroguaiaretic Acid, Oleanolic Acid, Benzyl Alcohol

Warnings

For external use only

Stop Use And Ask A Physician

If skin irritation and redness occurs more than 72 hours.

Do Not Use

On damaged or broken skin

Keep Out Of Reach Of Children

If swallowed, get medical help right away.

Other Information

Protect this product from direct sun and excessive heat

* Please review the disclaimer below.