NDC 10893-440 Dr Berrys Multi-purpose Sulfur Creme

Sulfur

NDC Product Code 10893-440

NDC 10893-440-04

Package Description: 120 mL in 1 JAR

NDC Product Information

Dr Berrys Multi-purpose Sulfur Creme with NDC 10893-440 is a a human over the counter drug product labeled by Nature's Innovation, Inc.. The generic name of Dr Berrys Multi-purpose Sulfur Creme is sulfur. The product's dosage form is cream and is administered via topical form.

Labeler Name: Nature's Innovation, Inc.

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.

Dr Berrys Multi-purpose Sulfur Creme 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 [hp_X]/120mL

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)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TEA TREE OIL (UNII: VIF565UC2G)

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: Nature's Innovation, Inc.
Labeler Code: 10893
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 12-14-2020 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: 12-31-2021 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.

Dr Berrys Multi-purpose Sulfur Creme Product Label Images

Dr Berrys Multi-purpose Sulfur Creme 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 1X HPUSThe letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

Purpose:

Acne, seborrheic dermatitis, mite, and tinea Symptom Relief

Uses:

Symptomatic treatment of acne, seborrheic dermatitis, mite, and tinea fungal infections.

Warnings:

For external use only. Ask a doctor before use if pregnant or nursing. Avoid using near eyes, mouth or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a doctor.

Directions:

Cleanse skin thoroughly before applying. Cover the affected skin area with creme once per day. If excessive drying of the skin or rash occurs,reduce the application of creme or discontinue use. To speed relief, we recommend using Dr.Berry’s Sulfur Soap with Lavender. Someindividuals may be sensitive to sulfur or essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

Inactive Ingredients:

Aqua, Carbomer, Cetearyl Alcohol, Glyceryl Stearate, Helianthus Annus ( Sunflower) Seed Oil, Phenoxyethanol, Polysorbate 20,Potassium Sorbate, Sodium Hydroxide, Tea Tree Oil.

* Please review the disclaimer below.