NDC 42731-076 Nenningers Naturals

Cuts Bruises Wounds

NDC Product Code 42731-076

NDC 42731-076-01

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Nenningers Naturals with NDC 42731-076 is a a human over the counter drug product labeled by Nenningers Naturals, Llc. The generic name of Nenningers Naturals is cuts bruises wounds. The product's dosage form is liquid and is administered via oral form.

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.

Nenningers Naturals 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • 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.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Nenningers Naturals, Llc
Labeler Code: 42731
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: 08-04-2021 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.

Nenningers Naturals 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

Otc - Active Ingredient

Active Ingredients: Arnica, Calendula, Hypericum, Lachesis, Ledum, Staphysagria, All HPUS. Purpose: Homeopathic medicine for symptom relief from cuts, bruises and wounds.

Otc - Purpose

Homeopathic medicine for symptom relief from cuts, bruises and wounds.

Inactive Ingredient

Inactive Ingredients: Alcohol, USP purified Water

Uses:

Promotes healing, reduce the severity of symptoms, and protect against infection from cuts, lacerations, scrapes, bruises, puncture, and surgical wounds.

Warnings:

If symptoms worsen or persist for more than 3 days consult a physician.If pregnant or breastfeeding consult a physician before use.
Keep out of reach of children.

Directions:

Take 1-3 times per day as needed. Place drops under the tongue or mix with 1 oz. of water. Adults: 20 drops

per dose. Children Age 2+: 2 drops for every 10 pounds of body weight up to

20 drops per dose. Best taken 15 minutes before or after food and drink.

Other Information:

Use only if safety seal is intact. Store at room temperature.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Pdp

Package: 30mL. NDC: 42731-076-01

* Please review the disclaimer below.