NDC 77200-003 Mystere Disinfecting Wipes

Pine Essential Oil

NDC Product Code 77200-003

NDC 77200-003-20

Package Description: 95 g in 1 POUCH

NDC Product Information

Mystere Disinfecting Wipes with NDC 77200-003 is a a human over the counter drug product labeled by Sy Global Inc. The generic name of Mystere Disinfecting Wipes is pine essential oil. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Sy Global 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.

Mystere Disinfecting Wipes 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.

  • PINUS DENSIFLORA WHOLE .4 g/100g

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.

  • LAMINARIA JAPONICA (UNII: WE98HW412B)
  • WATER (UNII: 059QF0KO0R)
  • CHAMAECYPARIS OBTUSA WHOLE (UNII: 80ZNL1G5XY)

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: Sy Global Inc
Labeler Code: 77200
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-04-2020 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.

Mystere Disinfecting Wipes 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

PINUS DENSIFLORA WHOLE(Pine Essential Oil) 0.4%

Purpose

Antimicrobial

Inactive Ingredients

WATER(Purified Water), LAMINARIA JAPONICA(Kelp Extract), CHAMAECYPARIS OBTUSA WHOLE(Chamaecyparis Obtusa Extract)

Use

Peel front label slowly

Pull out wipes as needed

Re-seal label after each use to prevent moisture loss

Caution

If any irritation develops, stop using and consult a doctor if necessary.

Do not use on damaged skin and avoid using on open scars.

Keep out of reach of children.

Keep in dry cool place, avoiding direct sunlight.Be careful when handling the packaging edges as they are sharp.

There is a risk of deterioration if you put the wipes back inside with contaminated hands.

Be sure to keep the sticker or cap closed after use.

* Please review the disclaimer below.