NDC 71328-060 Caring Mill Acne Drying

Sulfur

NDC Product Code 71328-060

NDC 71328-060-02

Package Description: 1 BOTTLE in 1 BOX > 29 mL in 1 BOTTLE (71328-060-01)

NDC Product Information

Caring Mill Acne Drying with NDC 71328-060 is a a human over the counter drug product labeled by Clixit, Llc. The generic name of Caring Mill Acne Drying is sulfur. The product's dosage form is lotion and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 240725.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Drying 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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • WATER (UNII: 059QF0KO0R)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • 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 Drying Product Label Images

Caring Mill Acne Drying 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 Ingredients

Sulfur 10%

Purpose

Acne Treatment

Use:

For the treatment of acne. Healing and drying of acne. Penetrates pores to control acne. Helps prevent breakouts.

Warnings:

For external use only.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.

Directions:

DO NOT SHAKE BOTTLE.Clean the skin thoroughly before using at night. Apply only to areas with acne. Allow solution to dry and rinse off in the morning.Do not use on broken skin or large areas of skin. If bothersome dryness or peeling occurs, reduce application to every other day.

Inactive Ingredients:

Allantoin, Aqua (Deionized Water), Camphor, Ethylhexylglycerin, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminium Silicate, Phenoxyethanol, Salicylic Acid, Zinc Oxide.

* Please review the disclaimer below.