NDC 73240-902 Sunmed Motion

Lidocaine

NDC Product Code 73240-902

NDC 73240-902-11

Package Description: 1 BOTTLE in 1 BOX > 74 mL in 1 BOTTLE

NDC Product Information

Sunmed Motion with NDC 73240-902 is a a human over the counter drug product labeled by Sunflora Inc. The generic name of Sunmed Motion is lidocaine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Sunflora 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.

Sunmed Motion 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 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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • PAPRIKA (UNII: X72Z47861V)
  • EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
  • CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • ALCOHOL (UNII: 3K9958V90M)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • TRIDECETH-6 (UNII: 3T5PCR2H0C)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Sunflora Inc
Labeler Code: 73240
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: 08-22-2019 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.

Sunmed Motion Product Label Images

Sunmed Motion 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 Ingredients

Lidocaine 4%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:• arthritis  • sprains  • simple backache  • muscle strains  • cramps  • bruises

Warnings

For external use onlyWhen 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 surfaces or blistered areas.Stop use and ask a doctor if• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

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 the affected area not more than 3 to 4 times daily.• Children under 2 years of age: Consult a doctor.

Inactive Ingredients

Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit Powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, Dimethicone, dl-alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) Seed Oil, Xanthan Gum.

* Please review the disclaimer below.