NDC 63264-201 Black Fly Guard

Neem

NDC Product Code 63264-201

NDC 63264-201-14

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Black Fly Guard with NDC 63264-201 is a a human over the counter drug product labeled by Resolutions Llc. The generic name of Black Fly Guard is neem. The product's dosage form is oil and is administered via topical form.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Black Fly Guard 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.


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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)

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.

Product Labeler Information

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

Labeler Name: Resolutions Llc
Labeler Code: 63264
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: 12-17-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Black Fly Guard 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

NEEM OIL 3%

Purpose

BLACK FLY GUARD

Uses

  • PREVENTS BLACK FLY BITESALL NATURAL PLANT OILSLONG LASTING PROTECTION

Warnings

TOPICAL OIL - FOR EXTERNAL USE ONLY - KEEP OUT OF EYES. FLUSH THOROUGHLY AND GENTLY WITH WARM WATER FOR 10-15 MINUTES. STOP USE AND CONSULT PHYSICIAN IF RASH OR IRRITATION DEVELOPS.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN: IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions

(FOR CHILDREN 2 YEARS AND OLDER AND ADULTS):APPLY SUNSCREEN FIRST, ESPECIALLY SPRAY-ON SUNSCREENS WHICH CONTAIN ALCOHOL (ALCOHOL REMOVES OUR PRODUCT). IF A SPRAY-ON SUNSCREEN IS REAPPLIED, THEN OUR PRODUCT MUST BE REAPPLIED TOO.

Other Ingredients

FRACTIONATED COCONUT OIL, OLIVE OIL, AVOCADO OIL, HIGH OLEIC SAFFLOWER OIL, CINNAMOM OIL, D-ALPHA TOCOPHEROL (VITAMIN E).

* Please review the disclaimer below.