NDC 71328-062 Caring Mill Acne Spot Treatment

Sulfur

NDC Product Code 71328-062

NDC 71328-062-02

Package Description: 1 TUBE in 1 BOX > 15 mL in 1 TUBE (71328-062-01)

NDC Product Information

Caring Mill Acne Spot Treatment with NDC 71328-062 is a a human over the counter drug product labeled by Clixit, Llc. The generic name of Caring Mill Acne Spot Treatment is sulfur. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 315220.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Caring Mill 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.


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 (SYNTHETIC) (UNII: 5TJD82A1ET)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • ZINC OXIDE (UNII: SOI2LOH54Z)

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: Clixit, Llc
Labeler Code: 71328
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: 06-21-2021 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.

Caring Mill Acne Spot Treatment Product Label Images

Caring Mill 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

Active Ingredient

Sulfur 10%

Purpose

Acne Treatment

Use:

For the treatment of acne

Warnings:

For external use only.When using this product• Do not use on broken skin or large areas of skin• Apply only to areas with acne• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time• If irritation occurs, only use one topical acne medication at a time• Stop use and ask a doctor if skin irritation occurs or gets worse• Rinse right away with water if product gets in eyes

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Directions:

• Clean the skin thoroughly before using• Apply a thin layer to entire affected area• 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 of peeling occurs, reduce application to once a day or every other day

Other Ingredients:

Aqua (Deionized Water), Camphor, Carbomer, Isopropyl Alcohol, Phenoxyethanol, Propylene Carbonate, Salicylic Acid, Tetrasodium EDTA, Triethanolamine, Zinc Oxide.

* Please review the disclaimer below.