NDC 68229-201 Alocane Emergency Burn

Lidocaine Hydrochloride

NDC Product Code 68229-201

NDC 68229-201-02

Package Description: 1 TUBE in 1 CARTON > 110 mL in 1 TUBE (68229-201-01)

NDC Product Information

Alocane Emergency Burn with NDC 68229-201 is a a human over the counter drug product labeled by Quest Products, Llc.. The generic name of Alocane Emergency Burn is lidocaine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Quest Products, Llc.

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.


Alocane Emergency Burn 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 4 g/100mL

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.

  • PROPANEDIOL (UNII: 5965N8W85T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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: Quest Products, Llc.
Labeler Code: 68229
FDA Application Number: part348 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: 03-01-2019 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.

Alocane Emergency Burn Product Label Images

Alocane Emergency Burn 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

Distributed by: Quest Products, Inc. Pleasant Prairie, WI 53158

Active Ingredient

Lidocaine HCL 4%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching associated with: Sunburn, Minor Burn, Insect Bites and Minor Skin Irritation, Cuts and Scrapes.

Warnings

For external use only. Avoid contact with eyes.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Stop Use

Stop use and ask doctor: if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health care professional before use.

Adults And Children 2 Years Of Age Or Older

Apply to affected area no more than 3 to 4 times daily. Children under 2 years of age, consult a physician. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Other Information

Store in a cool, dry area.

Inactive Ingredients

1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Chlorphenesin, Caprylyl Glycol, Tocopheryl Acetate (Vitamin E), Water.

* Please review the disclaimer below.

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