NDC 80771-001 Wild Horse 777 Oral

Phenol

NDC Product Code 80771-001

NDC 80771-001-15

Package Description: 1 BOTTLE in 1 BOX > 15 mL in 1 BOTTLE

NDC Product Information

Wild Horse 777 Oral with NDC 80771-001 is a a human over the counter drug product labeled by Wild Horse 777, Inc.. The generic name of Wild Horse 777 Oral is phenol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Wild Horse 777, 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.

Wild Horse 777 Oral 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.

  • PHENOL 6 mg/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)

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: Wild Horse 777, Inc.
Labeler Code: 80771
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 10-02-2020 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.

Wild Horse 777 Oral Product Label Images

Wild Horse 777 Oral 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:

Phenol 0.6%

Purpose:

Anesthetic/Analgesic

Uses

Temporarily relieves sore throate pain and minor mouth irritation.

Warnings

- Use only as directed. - The use of this container by more than one person may spread infection.

If Pregnant Or Breastfeeding,

Consult a health care professional before use.

Stop Use And Ask A Doctor

- if you experience any discomfort while using this product.- In case of overdose, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Directions

- 12 years old - adult:3 sprays.- 6-12 years old: 2 sprays.- 3-6 years old: 1 spray.- Children under age 3:1 spray. Consult a physician.- User should be in an upright position.- To use, remove cap, depress the pump completely to spray directly into mouth and throat.- Each spray is followed by a small sip of lukewarm water (<100 °F).- Swish water thoroughly for a few seconds, then swallow.- Day 1: every 3-4 hours.- Day 2: every 3-4 hours.- Day 3: twice a day.- Day 4: at bedtime.- Day 5: at bedtime.- Day 6-9: skip.- Day 10: at bedtime (final dose).

Other Information

- Store and use at room temperature.- Inspect the bottle for integrity. - Do not use if the safety seal is torn or broken.

Inactive Ingredient:

Purified mineral water

* Please review the disclaimer below.