NDC 71521-390 Diabetic First Aid Gel

Benzalkonium Chloride, Lidocaine Hydrochloride

NDC Product Code 71521-390

NDC 71521-390-50

Package Description: 50 g in 1 BOTTLE, PUMP

NDC Product Information

Diabetic First Aid Gel with NDC 71521-390 is a a human over the counter drug product labeled by Lavior Inc.. The generic name of Diabetic First Aid Gel is benzalkonium chloride, lidocaine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Lavior Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Diabetic First Aid Gel 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.

  • LIDOCAINE HYDROCHLORIDE .5 g/100g
  • BENZALKONIUM CHLORIDE .13 g/100g

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.

  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)
  • ALLANTOIN (UNII: 344S277G0Z)

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: Lavior Inc.
Labeler Code: 71521
FDA Application Number: part333A 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: 03-31-2021 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.

Diabetic First Aid Gel 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 Ingredients

Benzalkonium Chloride 0.13% .................Topical Antiseptic

Lidocaine Hydrochloride 0.5% .................Topical Analgesic

Purpose

Topical Antiseptic

Topical Analgesic

Uses

First aid to help prevent infection in minor:■cuts ■scrapes ■burnsTemporarily relieves pain and itching associated with:■minor burns ■cuts ■scrapes ■insect bites ■minor skin irritations

Warnings

For external use only

Do Not Use

  • In the eyesover large areas of the bodyin large quantities, particularly over raw surfaces or blistered areas

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsanimal bitesserious burns

Stop Use And Ask A Doctor If

  • Condition or symptoms get worse or last more than 1 weeksymptoms clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older:clean the affected areaapply a small amount of this product on the area 1 to 3 times dailymay be covered with a sterile bandageif bandaged, let dry firstChildren under 12 years of age: consult a doctor

Other Information

Store at room temperature

Inactive Ingredients

Water, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Aloe Barbadensis Leaf Juice, Xanthan Gum, Phenoxyethanol, Allantoin, Tocopheryl Acetate, Ethylhexylglycerin, Gluconolactone, Polyvinyl Alcohol, Alcohol, Citric Acid, Sodium Benzoate, Potassium Sorbate

Questions?

Call toll free 1-844-474-2552 or visit www.lavior.com

* Please review the disclaimer below.