NDC 0924-5200 Sting Relief

Alcohol, Lidocaine Hydrochloride

NDC Product Code 0924-5200

NDC 0924-5200-02

Package Description: 10 PACKET in 1 BOX > .9 mL in 1 PACKET (0924-5200-01)

NDC 0924-5200-03

Package Description: 50 PACKET in 1 BOX > .9 mL in 1 PACKET (0924-5200-01)

NDC Product Information

Sting Relief with NDC 0924-5200 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Sting Relief is alcohol, lidocaine hydrochloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Acme United Corporation

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It 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.

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.

  • ALCOHOL .5 mL/mL
  • LIDOCAINE HYDROCHLORIDE 20 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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • MENTHOL (UNII: L7T10EIP3A)
  • 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.

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
FDA Application Number: part333E 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: 03-06-2012 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: 12-31-2019 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.

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

Other

Drug Facts

Active Ingredient:

Ethyl Alcohol 50.0%
Lidocaine HCl 2.0%

Purpose:

Antiseptic
Analgesic (pain reliever)

Uses

  • First aid analgesic to help prevent infection in and provide temporary relief of the pain of:
  • Insect bites and stings
  • Minor scrapes and burns

Warnings:

For external use only. If swallowed, contact a doctor or poison control center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. Flammable, keep away from open flame.

Do Not Use:

  • In the eyes
  • If you are allergic to any of the ingredients
  • On raw surfaces, blistered areas, or over large areas of the body

When Using This Product:

  • Avoid contact with eyes or mucous membranes

Stop Use And Ask A Doctor If:

  • Conditions worsen clear up and then recur
  • The condition persists for more than 7 days
  • A rash, allergic reaction, swelling, irritation or infection occur

Directions:

Packets are not child resistant. Tamper evident packaging, do not use if packet is opened or torn.

Adults And Children:Over 2 Years Of Age:

Remove stinger carefully, if possible. Remove wipe from packet, clean affected area thoroughly no more than 3 times daily with saturated applicator.

Children Under 2:

Consult your doctor.

Other Information:

Store at room temperature.

Inactive Ingredients:

Benzalkonium Chloride, Menthol, Purified Water

Questions About This Product:

Call 800-835-2263 with any questions about this product.

* Please review the disclaimer below.