NDC 51532-3806 Afassco Burn Gel

Lidocaine

NDC Product Code 51532-3806

NDC 51532-3806-1

Package Description: 6 POUCH in 1 BOX > 3.5 g in 1 POUCH

NDC 51532-3806-2

Package Description: 24 POUCH in 1 BOX > 3.5 g in 1 POUCH

NDC Product Information

Afassco Burn Gel with NDC 51532-3806 is a a human over the counter drug product labeled by Afassco Inc.. The generic name of Afassco Burn Gel is lidocaine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Afassco 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.

Afassco Burn 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 70 mg/3.5g

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.

  • WATER (UNII: 059QF0KO0R)
  • MENTHOL (UNII: L7T10EIP3A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER 1342 (UNII: 809Y72KV36)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Afassco Inc.
Labeler Code: 51532
FDA Application Number: part346 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-25-2019 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.

Afassco Burn 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredientlidocaine 2%

Otc - Purpose

PurposePain Reliever

Indications & Usage

UsesCools, soothes, relieves pain,For First Aid Use of minor burns,scalds, and sunburns.

Warnings

WarningsFor external use only.Flammable: Keep away fromexcessine heat or open flame

Otc - Ask Doctor

Ask a doctor before use if youhave: sensitive skin

Otc - When Using

When using this product: Avoidcontact with eyes and mucosmembranes ● Do not apply towounds or damaged skin  ● Donot apply to irritated skinor if excessive irritation develops● Do not bandage  ● Wash handsafter use with cool water  ● Donot use with heating pad or device

Otc - Stop Use

Slop use and & a doctor if:Condition worsens, or ifsymptoms persist for more than7 days, or clear up and recur.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding:Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children:If accidentally ingested, getmedical help or contact a PoisonControl Center immediately.

Dosage & Administration

Directions● Adults & children over 2 yearsof age:  Rub a thin film overaffected areas no more than 4times a day - massage notnecessary ● Children under 2 years of age: Consult a physician

Other Safety Information

Other informationStore sealed packet in a cool dry place

Inactive Ingredient

Inactive ingredientsWater, Menthol, Propylene Glycol,Triethanolamine, Carbomer,Aloe Barbadensis Leaf Extract

Package Labeling

Afassco¦ ¦®The First Choice          in First AidAFASSCOBURN GEL WITH ALOE VERA​FOR FIRST AID USE ON MINOR BURNS, SCALDS, & SUNBURNNo.388                                                                                 6 ct.AFASSCOBURN GELWITH ALOE VERA6 ct.AFASSCOBURN GELWITH ALOE VERA6 ct.COOLS, SOOTHES, RELIEVES PAIN. FOR FIRST AID USEON MINOR BURNS, SCALDS, AND SUNBURN.INSTRUCTIONS: Apply a generous layer of Burn Gel to the affected area.Do not rub into skin. The skin should feel cool within 30 minutes.If the heat persists, reapply as needed. Twice daily use of Burn Gel willunlock the natural healing power of Aloe Vera to help revitalize the skin.WARNING: If redness or swelling persists for 7 days or if infection or rash develops,discontinue use and seek medical advice.REFRESCA, ALIVIA, SUAVIZA EL DOLOR, PARA UTILIZARCOMO PRIMEROS AUXILIOS EN PEQUEÑASQUEMADURAS, ESCALDADURAS Y QUEMADURAS DEL SOL.INSTRUCCIONES: Aplique na capa generosa de gel de grabación para la zonaafectada. No se frote en la piel. La piel debe estar frio en 30 minutos. Si el calorpersiste, volver a aplicar según sea necesario. Dos veces el uso diario de gel sedesbloqueará los recursos naturales poder curativo del Aloe Vera para ayudar arevitalizar la piel.ADVERTENCIAS: Si el enrojecimiento o la hinchazón persisten durante 7 días o sidesarrolla una infección o erupción cutánea, suspenda su uso y consultar al médico.INGREDIENTS: Water, Menthol, Propylene Glycol, Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract.Afassco¦ ¦® ANSI Z308.1               Manufactured for Afassco, Inc., Minden, NV 894236  70254 20388 76 Count Box Label24 Count Box Label Packet Labelres

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