NDC 61577-7055 Sore No More Warm Therapy Plus Cbd 500mg Natural Pain Relieving Gel

Menthol Camphor

NDC Product Code 61577-7055

NDC CODE: 61577-7055

Proprietary Name: Sore No More Warm Therapy Plus Cbd 500mg Natural Pain Relieving Gel What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol Camphor What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 61577 - Sombra Cosmetics Inc.

NDC 61577-7055-2

Package Description: 56.7 g in 1 JAR

NDC 61577-7055-4

Package Description: 113.4 g in 1 JAR

NDC Product Information

Sore No More Warm Therapy Plus Cbd 500mg Natural Pain Relieving Gel with NDC 61577-7055 is a a human over the counter drug product labeled by Sombra Cosmetics Inc.. The generic name of Sore No More Warm Therapy Plus Cbd 500mg Natural Pain Relieving Gel is menthol camphor. The product's dosage form is gel and is administered via topical form.

Labeler Name: Sombra Cosmetics Inc.

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.

Sore No More Warm Therapy Plus Cbd 500mg Natural Pain Relieving Gel 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.

  • MENTHOL .03 g/g
  • CAMPHOR (SYNTHETIC) .03 g/g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • WATER (UNII: 059QF0KO0R)
  • CAPSAICIN (UNII: S07O44R1ZM)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
  • ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)
  • ORANGE PEEL (UNII: TI9T76XD44)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)

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: Sombra Cosmetics Inc.
Labeler Code: 61577
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: 11-03-2020 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.

Sore No More Warm Therapy Plus Cbd 500mg Natural Pain Relieving Gel Product Label Images

Sore No More Warm Therapy Plus Cbd 500mg Natural Pain Relieving Gel 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

MENTHOL USP 3%, CAMPHOR USP 3%

Purpose

PURPOSEEXTERNAL ANALGESIC

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

TEMPORARILY RELIEVES MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH: SIMPLE BACKACHES

Warnings

​FOR EXTERNAL USE ONLY. ​DO NOT USE ON WOUNDS OR DAMAGED SKIN. WHEN USING THIS PRODUCTS: ​AVOID BANDAGING TIGHTLY, AVOID CONTACT WITH EYES, KEEP OUT OF REACH OF CHILDREN.​STOP USE AND ASK DOCTOR IF: CONDITION WORENS, SYMPTONS PERSIST FOR MORE THAN 7 DAYS, CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.

Directions

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY, RUB IN THOROUGHLY UNTIL GEL IS ABSORBED, CHILDREN UNDER 2 YEARS OF AGE: ​CONSULT A DOCTOR.

Inactive Ingredients

Aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol, cannabidiol, capsicum annuum fruit extract,

* Please review the disclaimer below.