NDC 63347-223 Hempnesic

Menthol, Camphor

NDC Product Code 63347-223

NDC 63347-223-01

Package Description: 88.7 mL in 1 TUBE

NDC 63347-223-08

Package Description: 236.58 mL in 1 TUBE

NDC Product Information

Hempnesic with NDC 63347-223 is a a human over the counter drug product labeled by Blaine Labs Inc.. The generic name of Hempnesic 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.

Hempnesic 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
  • 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)
  • CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
  • CARBOMER 1342 (UNII: 809Y72KV36)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • 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.
  • 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: 04-01-2018 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Hempnesic Product Label Images

Hempnesic 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

Drug Factsactive Ingredients:

Menthol 3.5%Camphor 0.2%

Purpose

Topical Analgesic

Uses

For temporary relief from minor aches andpains of sore muscles and joints asociated with:• arthritis pain • backache • strains • sprains

Warnings:

For external use only.

Flammable:

Keep away from excessive heat or open flame.

Ask A Doctor Before Use If You Have:

Sensitive skin

When Using This Product:

• Avoid contact with the eyes and/or mucous membranes • Do not use withother sprays, ointments, creams or liniments • Do not apply to irritated skin, & discontinue use if excessiveskin irritation develops • Do not bandage • Do not use with heating pads or device

Stop Use And Contact Your Physician If:

Conditions worsen, or if symptoms persist for more than seven (7)days, or clear up and reoccur.

If Pregnant Or Breast-Feeding:

Ask a health professional before use

Children Under 2 Years Of Age:

Consult physician

Keep Out Of Reach Of Children:

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

Directions:

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

Other Information:

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

Inactive Ingredients:

Ethyl Alcohol Denatured, Deionized Water, Menthol, Camphor, 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, Hexylene Glycol

Hempnesic®Pain-Relieving Gel

NDC 63347-223-01BLAINE LABS®HempNesic ®PAIN-RELIEVING GELMENTHOL AND CAMPHORIN A GEL CONTAININGCAPSAICIN & HEMP OIL3.0 OZ (88.7 mL)DRUG FACTSActive Ingredients                                   PurposeMenthol 3.5% ................................Topical AnalgesicCamphor 0.2% ..............................Topical AnalgesicUses: For temporary relief from minor aches andpains of sore muscles and joints asociated with:• arthritis pain • backache • strains • sprainsWarnings: For external use only.Flammable: Keep away from excessive heat or open flame.Ask a doctor before use if you have: Sensitive skinWhen using this product: • Avoid contact with theeyes and/or mucous membranes • Do not use withother sprays, ointments, creams or liniments • Do notapply to irritated skin, & discontinue use if excessiveskin irritation develops • Do not bandage • Do not usewith heating pads or deviceStop use and contact your physician if: conditionsworsen, or if symptoms persist for more than seven (7)days, or clear up and reoccur.If pregnant or breast-feeding: Ask a healthprofessional before useChildren under 2 years of age: Consult physicianKeep Out Of Reach Of Children: If swallowed, getmedical help or contact a poison control center immediately.Directions: Use only as directed. Rub a thin filmover the affected areas not more than four (4) timesdaily. Rinse hands after use with cool water.Other Information: Store in a cool, dry place with lid closed tightly.Inactive Ingredients: Ethyl Alcohol Denatured, D.I. Water,Glycerin, Propylene Glycol, Cannabis Sativa Seed Oil (Hemp Seed Oil ),Cannabidiol (Cbd), Arnica Montana Flower Extract (Arnica Oil),Mentha Piperita (Peppermint) Oil, Hydroxyethylcellulose, Carbomer,Triethanolamine, Mentha Viridis (Spearmint) Leaf Oil, CamelliaSinensis 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, Hexylene GlycolManufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670Questions or Comments? Call (800) 307-8818 M-F 8am - 5pm (PST) *MADE IN THE USAHempnesic_223_01.jpg

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