NDC 63788-115 Lido E.r.creme Roll On

Lidocaine Hcl

NDC Product Code 63788-115

NDC 63788-115-04

Package Description: 113 g in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Lido E.r.creme Roll On with NDC 63788-115 is a a human over the counter drug product labeled by Pharma-natural. The generic name of Lido E.r.creme Roll On is lidocaine hcl. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pharma-natural

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Lido E.r.creme 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 4 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.

  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • TRIDECETH-6 (UNII: 3T5PCR2H0C)
  • WATER (UNII: 059QF0KO0R)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)

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: Pharma-natural
Labeler Code: 63788
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: 02-14-2020 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.

Lido E.r.creme Roll On Product Label Images

Lido E.r.creme 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

Otc - Purpose

Active ingredientPurposeLidocaine HCL 4%............................Topical analgesic

Use

For the temporary relief of pain.

Warnings

For external use only. Avoid contact with the eyes.

Do Not Use

In large quantities, particularly over raw surfaces, or blistered areas.

Stop Use And Ask A Doctor If

Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

▪adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
▪children under 2 years of age: consult a doctor

Other Information

▪ store in a cool dry place between (59-86°F)15-30°C▪ don’t use if seal over cap is broken, torn, or missing

Inactive Ingredients

Caprylhydroxamic acid, caprylyl glycol, cyclomethicone 5, dimethicone, dimethyl sulfone, eucalyptus oil, glycerin, glyceryl monostearate, glycol stearate, methylpropanediol, PEG-100 stearate, PEG/PPG-18/18-dimethicone, phenoxyethanol, sodium lauryl sulfate, sodium polyacrylate, stearyl alcohol, sweet almond oil, trideceth-6, water

Distributed By:

Diabetic Supplu of Suncoast, Inc. PO Box 2102, Vega Alta, PR 00692

* Please review the disclaimer below.