NDC 0924-5250 First Aid Only Sting Relief

Benzocaine

NDC Product Code 0924-5250

NDC 0924-5250-01

Package Description: 10 AMPULE in 1 CARTON > 6 mL in 1 AMPULE

NDC Product Information

First Aid Only Sting Relief with NDC 0924-5250 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of First Aid Only Sting Relief is benzocaine. The product's dosage form is swab and is administered via topical form.

Labeler Name: Acme United Corporation

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

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 Sting Relief 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.

  • BENZOCAINE .12 g/.6mL
  • MENTHOL .006 g/.6mL

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.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • WATER (UNII: 059QF0KO0R)
  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)

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: 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: 02-01-2010 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 Sting Relief Product Label Images

First Aid Only Sting Relief 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

Benzocaine 20 percent

Menthol 1 percent

Otc - Purpose

Topical AnalgesicTopical Analgesic

Indications & Usage

UsesFor temporary relief of the pain and itching of•insect bites and stings•minor scrapes and burns

Warnings

WarningsFor external use only.Do not use •in the eyes •if you are allergic to any of the ingredientsStop use and ask a doctor if •conditions worsen •symptoms clear up and then recur •the condition persists for more than 7 days

Otc - Keep Out Of Reach Of Children

Keep out of the reach of childrenIf swallowed, contact Poison Control 800.222.1222, or a doctor immediately.

Dosage & Administration

Directions If stinger is present, remove carefully if possible.
Adults Reverse cardboard sleeve so swab is visible. With cardboard sleeve on ampile, crush at dot on sleeve. There will be a "pop" and the swab will become saturated. Apply saturated applicator to the affected area no more than 3 to 4 times daily.Children under 2 Consult a doctor.

Information For Patients

Other InformationStore at room temperature.

Inactive Ingredient

D&C Green no. 5, D&C yellow no.10, FD&C blue no.1, isopropyl alcohol, polyethylene glycol 300, purified water

Otc - Questions

Questions 800.835.2263

* Please review the disclaimer below.