NDC 77375-007 Pain Relief Roll On Evora Labs

Lidocaine

NDC Product Code 77375-007

NDC 77375-007-02

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 74 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Pain Relief Roll On Evora Labs with NDC 77375-007 is a a human over the counter drug product labeled by Evora Worldwide. The generic name of Pain Relief Roll On Evora Labs is lidocaine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Evora Worldwide

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.

Pain Relief Roll On Evora Labs 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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • MYRISTYL TRISILOXANE (UNII: J7960S4R1T)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETETH-20 PHOSPHATE (UNII: 921FTA1500)
  • DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ALCOHOL (UNII: 3K9958V90M)
  • STEARETH-21 (UNII: 53J3F32P58)
  • 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: Evora Worldwide
Labeler Code: 77375
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: 12-22-2020 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.

Pain Relief Roll On Evora Labs Product Label Images

Pain Relief Roll On Evora Labs 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 Ingredient                                               Purpose

Lidocaine 4%..................................................... Topical analgesic

Uses

For temporary relief of pain and itching

Warnings

For externa use only.When using this product • use only as directed • do not bandage tightly • avoid contact with


eyes  • do not apply to wounds or  damaged skin • do not use in large quantities, particularly over raw 
surface or blistered areas.

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


Flammable • keep away from fire or flame


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 right away.

Directions

• Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily


• Children under 2 years old: consult a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer


ALOE VERA LEAF


AMINOMETHYLPROPANOL 


Caprylyl Methicone


CETOSTEARYL ALCOHOL


CETETH-20 PHOSPHATE


DIHEXADECYL PHOSPHATE 


DIMETHICONE 


EDETATE DISODIUM


Ethylhexylglycerin 


GLYCERYL STEARATE


METHYLPARABEN 


SD ALCOHOL 40


STEARETH-21 


WATER

Questions?

1-888-793-8450

* Please review the disclaimer below.