NDC 76348-446 Clixit Acne Spot Treatment

Sulfur Acne Treatment

NDC Product Code 76348-446

NDC 76348-446-02

Package Description: 1 TUBE in 1 BOX > 14 g in 1 TUBE (76348-446-01)

NDC Product Information

Clixit Acne Spot Treatment with NDC 76348-446 is a a human over the counter drug product labeled by Renu Laboratories, Inc.. The generic name of Clixit Acne Spot Treatment is sulfur acne treatment. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Renu Laboratories, Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Clixit Acne Spot Treatment 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.

  • SULFUR 1.4 g/14g

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)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • ALCOHOL (UNII: 3K9958V90M)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)

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: Renu Laboratories, Inc.
Labeler Code: 76348
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: 10-02-2019 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: 12-31-2020 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.

Clixit Acne Spot Treatment 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 10 percent

Otc - Purpose

PurposeAcne Treatment

Indications & Usage

Use ForFor the treatment of acne

Warnings

WarningsFor external use onlyUsing other topical acne medications at the same time may increase dryness or irritation of the skin. 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 occurs, reduce application to once per day.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, contact physician or poison control center immediately.

Other Safety Information

Store at room temperature

Dosage & Administration

DirectionsClean the skin thoroughly before using. Apply directly to blemish or affected area. Do not use on broken skin or large areas of the skin. For best results, use 2-3 times per day.

Otc - Do Not Use

Do not use on broken skin or large areas of skin.

Inactive Ingredient

Other IngredientsCamphor, Carbomer, Deionized Water, EDTA (Ethylenediamine Tetraacetic Acid), Ethanol, Ethylhexylglycerin, Phenoxyethanol, Propylene Carbonate, Salicylic Acid, Triethanolamine (TEA)

Other IngredientsCamphor, Carbomer, Deionized Water, EDTA (Ethylenediamine Tetraacetic Acid), Ethanol, Ethylhexylglycerin, Phenoxyethanol, Propylene Carbonate, Salicylic Acid, Triethanolamine (TEA)

Otc - Questions

QUESTIONSCall 844 425 4948

Statement Of Identity

ACNE SPOT TREATMENTWITH 10 percent sulfur

* Please review the disclaimer below.