NDC 11086-028 Liquimat Acne Treatment And Cover-up

Sulfur

NDC Product Code 11086-028

NDC 11086-028-01

Package Description: 44 mL in 1 BOTTLE

NDC Product Information

Liquimat Acne Treatment And Cover-up with NDC 11086-028 is a 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.

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.

Liquimat Acne Treatment And Cover-up 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.

  • 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)

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: Summers Laboratories Inc
Labeler Code: 11086
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: 10-30-2013 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.

Liquimat Acne Treatment And Cover-up Product Label Images

Liquimat Acne Treatment And Cover-up 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

Otc - Active Ingredient

ACTIVE INGREDIENTSULFUR 4%

Otc - Purpose

PURPOSEACNE TREATMENT LOTION

Indications & Usage

USEDRIES UP ACNE PIMPLES, HELPS PREVENT NEW PIMPLES

Warnings

  • WARNINGSFOR EXTERNAL USE ONLY

Otc - Do Not Use

  • DO NOT USEON BROKEN SKINON LARGE AREAS OF THE BODY

Otc - When Using

  • WHEN USING THIS PRODUCTAPPLY TO AFFECTED AREAS ONLYDO NOT GET INTO EYESUSING 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 IFTOO 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

  • DIRECTIONSCLEAN SKIN THOROUGHLY BEFORE USINGCOVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES DAILYBECAUSE 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 INGREDIENTSWATER, 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.