NDC 64616-069 Olive Leaf Acne Remedy

Topical Skin Relief

NDC Product Code 64616-069

NDC 64616-069-02

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 30 mL in 1 BOTTLE, PLASTIC (64616-069-01)

NDC Product Information

Olive Leaf Acne Remedy with NDC 64616-069 is a a human over the counter drug product labeled by Vitality Works, Inc. The generic name of Olive Leaf Acne Remedy is topical skin relief. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Vitality Works, Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Olive Leaf Acne Remedy 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.

  • 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

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)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • CITRUS PARADISI SEED (UNII: 12F08874Y7)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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.
  • 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: Vitality Works, Inc
Labeler Code: 64616
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: 04-20-2011 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.

Olive Leaf Acne Remedy 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

Olive Leaf Acne Remedy

Antimonium crudum 12XCalcarea sulfurica 12XJuglans regia 6XSulphur iodatum 30X

USP Purified Water, Xylitol powder, Sodium Chloride, Olive Leaf Extract (Olea europa) 4X, Grapefruit Seed Extract, Sodium Hydroxide (for pH balance)

-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.

Keep this and all drugs out of the reach of children. For children under 3 years of age, consult a health care professional.

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.

- 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.

Antimonium crudum - Relieves pimples; pustular eruptions with burning and itching; eczemaCalcarea sulfurica - Relieves pimples and pustules on the face and under hairJuglans regia - Relives acne; itching; pimples on face, neck, shoulder and backSulphur iodatum - Relieves acne, itching; cold sores on lips; pustules on uppler lip

* Please review the disclaimer below.