NDC 61727-336 Skin Klear Acne Relief

Tribasic Calcium Phosphate, Fumaria Officinalis Flowering Top, Arctium Lappa Root, Sodium Chloride, Saponaria Officinalis Root, Silicon Dioxide, Solidago Virgaurea Flowering Top, Sulfur, Viola Tricolor

NDC Product Code 61727-336

NDC Code: 61727-336

Proprietary Name: Skin Klear Acne Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Tribasic Calcium Phosphate, Fumaria Officinalis Flowering Top, Arctium Lappa Root, Sodium Chloride, Saponaria Officinalis Root, Silicon Dioxide, Solidago Virgaurea Flowering Top, Sulfur, Viola Tricolor What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 61727 - Homeocare Laboratories
    • 61727-336 - Skin Klear Acne Relief

NDC 61727-336-21

Package Description: 4 g in 1 TUBE

NDC Product Information

Skin Klear Acne Relief with NDC 61727-336 is a a human over the counter drug product labeled by Homeocare Laboratories. The generic name of Skin Klear Acne Relief is tribasic calcium phosphate, fumaria officinalis flowering top, arctium lappa root, sodium chloride, saponaria officinalis root, silicon dioxide, solidago virgaurea flowering top, sulfur, viola tricolor. The product's dosage form is pellet and is administered via sublingual form.

Labeler Name: Homeocare Laboratories

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Skin Klear Acne Relief 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.

  • TRIBASIC CALCIUM PHOSPHATE 10 [hp_X]/4g
  • FUMARIA OFFICINALIS FLOWERING TOP 4 [hp_C]/4g
  • ARCTIUM LAPPA ROOT 4 [hp_C]/4g
  • SODIUM CHLORIDE 12 [hp_X]/4g
  • SAPONARIA OFFICINALIS ROOT 4 [hp_C]/4g
  • SILICON DIOXIDE 5 [hp_C]/4g
  • SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_C]/4g
  • SULFUR 5 [hp_C]/4g
  • VIOLA TRICOLOR 4 [hp_C]/4g

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.

  • SUCROSE (UNII: C151H8M554)
  • LACTOSE (UNII: J2B2A4N98G)

Administration Route(s)

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

  • Sublingual - Administration beneath the tongue.

Product Labeler Information

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

Labeler Name: Homeocare Laboratories
Labeler Code: 61727
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: 07-24-2012 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.

Skin Klear Acne Relief Product Label Images

Skin Klear Acne Relief 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:

Calcarea phos. 10X, Fumaria off. 4C, Lappa major 4C, Natrum mur. 12X, Saponaria 4C, Silicea 5C, Solidago 3C, Sulphur 5C, Viola tricolor 4C.

Inactive Ingredients:

Sucrose/lactose.

Purpose:

For the temporary relief of acne vulgaris and skin inflammation.

Keep Out Of Reach Of Children.

Keep out of reach of children.

Indications & Usage:

Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

Warnings:

If symptoms persist or worsen, or if pregnant or nursing, consult a doctor. Keep out of reach of children. Do not use if cap seal is broken or missing.

Dosage & Administration:

Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

Skin Klear Acne Relief

Skin Klear Acne ReliefHomeopathic Medicine85 Pelletshcl_label_SkinKlear-2012.jpg

* Please review the disclaimer below.

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