Olive Leaf Acne Remedy

Topical Skin Relief

Vitality Works, Inc
Human Otc Drug
NDC 64616-069

Olive Leaf Acne Remedy also known as Topical Skin Relief is a human otc drug labeled by 'Vitality Works, Inc'. National Drug Code (NDC) number for Olive Leaf Acne Remedy is 64616-069. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Olive Leaf Acne Remedy drug includes Antimony Trisulfide - 12 [hp_X]/mL Calcium Sulfate Anhydrous - 12 [hp_X]/mL Juglans Regia Flowering Top - 6 [hp_X]/mL Sulfur Iodide - 30 [hp_X]/mL . The currest status of Olive Leaf Acne Remedy drug is Active.

Drug Information:

Drug NDC:	64616-069
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Olive Leaf Acne Remedy
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Topical Skin Relief
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Vitality Works, Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ANTIMONY TRISULFIDE - 12 [hp_X]/mL CALCIUM SULFATE ANHYDROUS - 12 [hp_X]/mL JUGLANS REGIA FLOWERING TOP - 6 [hp_X]/mL SULFUR IODIDE - 30 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	20 Apr, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Vitality Works, Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0019277000675
UPC stands for Universal Product Code.
UNII:	F79059A38U E934B3V59H 3BA2N709NG L6L8KA2AA0
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Blood Coagulation Factor [EPC] Calcium [CS] Cations Divalent [CS] Increased Coagulation Factor Activity [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
64616-069-02	1 BOTTLE, PLASTIC in 1 CARTON (64616-069-02) / 30 mL in 1 BOTTLE, PLASTIC (64616-069-01)	20 Apr, 2011	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Olive Leaf Acne Remedy

Topical Skin Relief

Liquid
Vitality Works, Inc
NDC: 64616-069

Olive-viate

Topical Skin Relief

Liquid
Vitality Works, Inc.
NDC: 64616-042

Purpose:

Olive leaf acne remedy antimonium crudum - relieves pimples; pustular eruptions with burning and itching; eczema calcarea sulfurica - relieves pimples and pustules on the face and under hair juglans regia - relives acne; itching; pimples on face, neck, shoulder and back sulphur iodatum - relieves acne, itching; cold sores on lips; pustules on uppler lip

Product Elements:

Olive leaf acne remedy topical skin relief benzalkonium chloride water olea europaea leaf sodium hydroxide antimony trisulfide antimony trisulfide calcium sulfate anhydrous calcium cation juglans regia flowering top juglans regia flowering top sulfur iodide sulfur iodide magnesium disodium edta

Indications and Usage:

Olive leaf acne remedy for the temporary relief of symptoms of acne, pimples, and cold sores. for the temporary relief of eczema, burning and itching, and skin pustular eruptions.

Warnings:

Olive leaf acne remedy -do not apply in or around eyes. this product will sting your eyes. if product should get into your eyes, rinse with warm water. -as with any drug. if you are pregnanat or nursing a baby, seek the advice of a health care professional before using this product. -in case of accidental overdose by ingestion, seek profesional assistance or contact a poison control center immediately. all the ingredients are edible. however this product is not designed for internal use.

Dosage and Administration:

Olive leaf acne remedy - first, thoroughly wash hands and the affected areas of the skin with warm soapy water, and rinse. dry thoroughly. - apply a drop to fingertip and gently apply on affected skin. - repeat 2-3 times per day. - for best results, continue using for a least one week after syptoms disappear. - reapply if symptoms return.

Package Label Principal Display Panel:

Olive leaf acne remedy olive leaf acne remedy carton

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.