NDC 11086-028 Liquimat Acne Treatment And Cover-up
Sulfur Liquid Topical

Product Information

Product Code11086-028
Proprietary Name 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.
Liquimat Acne Treatment And Cover-up
Non-Proprietary Name 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.
Sulfur
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Summers Laboratories Inc
Labeler Code11086
FDA Application Number 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.
part333D
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-30-2013
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 11086-028-01

Package Description: 44 mL in 1 BOTTLE

Product Details

Liquimat Acne Treatment And Cover-up is a human over the counter drug product labeled by Summers Laboratories Inc. The generic name of Liquimat Acne Treatment And Cover-up is sulfur. The product's dosage form is liquid and is administered via topical form.


What are Liquimat Acne Treatment And Cover-up Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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)
  • ALCOHOL (UNII: 3K9958V90M)
  • KAOLIN (UNII: 24H4NWX5CO)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TALC (UNII: 7SEV7J4R1U)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLOXAMER 182 (UNII: JX0HIX6OAG)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PEG-8 LAURATE (UNII: 762O8IWA10)
  • DIMETHICONE (UNII: 92RU3N3Y1O)


* Please review the disclaimer below.

Liquimat Acne Treatment And Cover-up Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



ACTIVE INGREDIENT

SULFUR 4%


Otc - Purpose



PURPOSE

ACNE TREATMENT LOTION


Indications & Usage



USE

DRIES UP ACNE PIMPLES, HELPS PREVENT NEW PIMPLES


Warnings



WARNINGS

  • FOR EXTERNAL USE ONLY

Otc - Do Not Use



DO NOT USE

  • ON BROKEN SKIN
  • ON LARGE AREAS OF THE BODY

Otc - When Using



WHEN USING THIS PRODUCT

  • APPLY TO AFFECTED AREAS ONLY
  • DO NOT GET INTO EYES
  • USING OTHER TOPICAL ACNE DRUGS AT THE SAME TIME OR RIGHT AFTER USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE DRUG SHOULD BE USED UNLESS DIRECTED BY A DOCTOR

Otc - Stop Use



STOP USE AND ASK A DOCTOR IF

  • TOO MUCH IRRITATION DEVELOPS OR INCREASES

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.


Dosage & Administration



DIRECTIONS

  • CLEAN SKIN THOROUGHLY BEFORE USING
  • COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES DAILY
  • BECAUSE TOO MUCH DRYING OF THE SKIN MAY OCCUR, START WITH 1 APPLICATION DAILY, THEN INCREASE TO 2 TO 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR.

Inactive Ingredient



INACTIVE INGREDIENTS

WATER, SD-40 ALCOHOL 22-PERCENT, KAOLIN, ZINC OXIDE, GLYCERIN, TITANIUM DIOXIDE, TALC, CELLULOSE GUM, MAGNESIUM ALUMINUM SILICATE, CETYL ALCOHOL, POLOXAMER 182, FRAGRANCE, IRON OXIDES. COLOR MATCHER CONTAINS IRON OXIDES, PEG-8, PEG-8 LAURATE, SIMETHICONE.


* Please review the disclaimer below.