NDC 66902-235 Fast Freeze Lidocaine Roll-on

Lidocaine Hydrochloride, Benzyl Alcohol

NDC Product Code 66902-235

NDC 66902-235-03

Package Description: 89 mL in 1 CONTAINER

NDC Product Information

Fast Freeze Lidocaine Roll-on with NDC 66902-235 is a a human over the counter drug product labeled by Natural Essentials, Inc.. The generic name of Fast Freeze Lidocaine Roll-on is lidocaine hydrochloride, benzyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Natural Essentials, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Fast Freeze Lidocaine Roll-on 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 40 mg/mL
  • BENZYL ALCOHOL 10 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.

  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • TROLAMINE (UNII: 9O3K93S3TK)

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.
  • 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: Natural Essentials, Inc.
Labeler Code: 66902
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: 07-10-2020 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: 12-31-2021 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.

Fast Freeze Lidocaine Roll-on Product Label Images

Fast Freeze Lidocaine Roll-on 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 Ingredients

Lidocaine HCl 4%
Benzyl Alcohol 10%

Purpose

Topical Anesthetic
Topical Anesthetic

Uses

Temporary relief of minor pain

Warnings

For external use only
FLAMMABLE:Keep away from fire or flame

Do Not Use

  • On wounds or damaged skin
  • In large quantities
  • With a heating pad
  • If you are allergic to any ingredients of this product

When Using This Product

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Stop Use And Ask A Doctor If

  • Skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

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

Directions

  • Adults and children 12 years of age and over
  • Clean and dry affected area
  • Apply to affected area not more than 3 to 4 times daily children 12 years or younger ask a doctor

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Citric Acid, Deionized Water, SDA 40-B Alcohol, Tromethamine

* Please review the disclaimer below.