NDC 78565-106 Sulfur

Sulfur Soap

NDC Product Code 78565-106

NDC 78565-106-02

Package Description: 240 g in 1 BOX

NDC Product Information

Sulfur with NDC 78565-106 is a a human over the counter drug product labeled by Meixin Beauty & Health Care Products Co., Ltd.. The generic name of Sulfur is sulfur soap. The product's dosage form is soap and is administered via cutaneous form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2586352.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Sulfur 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Cutaneous - Administration to the skin.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Meixin Beauty & Health Care Products Co., Ltd.
Labeler Code: 78565
FDA Application Number: part358H 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: 12-25-2021 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.

Sulfur 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

Sulfur10.0% ,Salicylic Acid3.0%


Acne Treatment


For external use only

Do Not Use

On broken skin on large areas of the skin

When Using This Product

Apply only to areas with acne.Do not allow contact with the eyes and mucous membranes.If undue skin irritation develops or increases , discontinue use and consult a physician.Skin irritation and dryness are more likely to occur if you use another topical medication at the same time.If irritation occurs , only use one topical acne medication at a time.

Otc - Stop Use

If undue skin irritation develops or increases , discontinue use and consult a physician.

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.


Make lather with sponge.Apply to affected areas.Leave lather on skin for 3 to 5 minutes.Rinse thoroughly with water and gently pat dry with a clean toweI.May be used 1 to 3 times a day or as directed by a doctor

Make lather with sponge.Apply to affected areas.Leave lather on skin for 3 to 5 minutes.Rinse thoroughly with water and gently pat dry with a clean toweI.May be used 1 to 3 times a day or as directed by a doctor

Inactive Ingredients

Sodium palmitate, Sodium palm kernelate, Water , Glycerin , Tetrasodium EDTA ,Soyethyl morpholinium ethosulfate , Lavender essential oil


For use in the management of acne.Dries up blackheads and whiteheads.Penetrates pores to eliminate most acne pimples.Helps keep skin clear of new acne blemishes

* Please review the disclaimer below.