NDC 63347-225 Cbdezic

Menthol, Camphor

NDC Product Code 63347-225

NDC 63347-225-17

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 50.275 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Cbdezic with NDC 63347-225 is a a human over the counter drug product labeled by Blaine Labs Inc.. The generic name of Cbdezic is menthol, camphor. The product's dosage form is gel and is administered via topical form.

Labeler Name: Blaine Labs 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.


Cbdezic 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 3.5 g/100mL
  • CAMPHOR (SYNTHETIC) .2 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PAPRIKA (UNII: X72Z47861V)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLIC ALCOHOL (UNII: NV1779205D)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)

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: Blaine Labs Inc.
Labeler Code: 63347
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-01-2019 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.

Cbdezic Product Label Images

Cbdezic 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

Otc - Active Ingredient

ACTIVE INGREDIENTSMenthol 3.5%Camphor 0.2%

Otc - Purpose

PurposeMenthol ...........Topical AnalgesicCamphor ............Topical Analgesic

Indications & Usage

USES: For temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis pain • backache • strains • sprains

Warnings

WARNINGS: For external use only.

Other Safety Information

Flammable: Keep away from excessive heat or open flame.

Children under 2 years of age: Consult physician

OTHER INFORMATION: Store in a cool, dry place with lid closed tightly.

Otc - Ask Doctor

Ask a doctor before use if you have:Sensitive skin

Otc - When Using

When using this product: • Avoid contact with the eyes and/or mucous membranes • Do not use with other sprays, ointments, creams or liniments • Do not apply to irritated skin • Discontinue use if excessive skin irritation develops • Do not bandage • Do not use with heating pads or devices

Otc - Stop Use

Stop use and contact your physician if:conditions worsen, or if symptoms persist for more than seven (7) days, or clear up and reoccur.

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: If swallowed, get medical help or contact a poison control center immediately.

Dosage & Administration

DIRECTIONS: Use only as directed. Rub a thin film over the affected areas not more than four (4) times daily. Rinse hands after use with cool water.

Inactive Ingredient

INACTIVE INGREDIENTS: Ethyl Alcohol, Deionized Water, Glycerin, Propylene Glycol, Cannabis Sativa Seed Oil (Hemp Seed Oil), Cannabidiol (CBD), Arnica Montana Flower Extract (Arnica Oil), Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Capsicum Annuum Fruit Extract, Phenoxyethanol, Caprylyl Alcohol, Ethylhexyl Glycerin, HexyleneGlycol

Principal Display Package

Dr. Blaine's®CBDEZIC+®MEDICAL GRADE PAIN-RELIEVING GELMAXIMUM PAINRELIEFNDC# 63347-225-17Dr. Blaine's®                                                       50MGCBDEZIC+®MEDICAL GRADE PAIN-RELIEVING GEL1.7 fl oz (50.275mL)6  16728 00095  870001-BX     REV20190315PHYSICIAN FORMULATED PAIN-RELIEF GELMAXIMUMPAINRELIEF• Goes on cool and   progressively heats• Infused with capsaicin,   hemp oil, and tea tree oil• Paraben-free formulation• Light formula absorbs into   the skin rapidly• Longer lasting formula. One   application offers relief for   up to 4-6 hours• Provides fast relief from sore   muscles, aches and pain           H                        THC√FreeHEMP DERIVEDMADE IN THE USAMANUFACTURED BY:BLAINE LABS, INC.11037 LOCKPORT PLACE,SANTA FE SPRINGS, CA 90670www.BLAINELABS.comres

* Please review the disclaimer below.

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