NDC 0924-5401 First Aid Only Ammonia Inhalants

Ammonia Inhalants

NDC Product Code 0924-5401

NDC 0924-5401-01

Package Description: 10 AMPULE in 1 CARTON > .3 mL in 1 AMPULE

NDC 0924-5401-02

Package Description: 100 AMPULE in 1 CARTON > .3 mL in 1 AMPULE

NDC Product Information

First Aid Only Ammonia Inhalants with NDC 0924-5401 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of First Aid Only Ammonia Inhalants is ammonia inhalants. The product's dosage form is inhalant and is administered via respiratory (inhalation) form.

Labeler Name: Acme United Corporation

Dosage Form: Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.

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.

First Aid Only Ammonia Inhalants 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.

  • AMMONIA .045 g/.3mL

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.

  • LEMON OIL (UNII: I9GRO824LL)
  • WATER (UNII: 059QF0KO0R)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ALCOHOL (UNII: 3K9958V90M)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • NUTMEG OIL (UNII: Z1CLM48948)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Product Labeler Information

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

Labeler Name: Acme United Corporation
Labeler Code: 0924
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: 01-01-2006 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.

First Aid Only Ammonia Inhalants Product Label Images

First Aid Only Ammonia Inhalants 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 IngredientAmmonia(15%)

Otc - Purpose

PurposeAromatic Stimulant

Indications & Usage

Uses To prevent or treat fainting

Warnings

Warnings For external use only.
Do not use •If you have breathing problems such as asthma or emphysema
Stop use and ask a doctor if condition persists

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Dosage & Administration

Directions Hold inhalant away from face and crush between thumb and forefinger. Carefully approach crushed inhalant to nostrils of affected person.

Information For Patients

Other Information Store at room temperarure, away from light

Inactive Ingredient

Inactive Ingredients Alcohol USP, FD&C Red Dye #40, Lavender Oil NF, Lemon Oil NF, Nutmeg Oil NF, Purified Water USP

Otc - Questions

Questions 1.800.835.2263

* Please review the disclaimer below.