NDC 66902-778 Cvs Arnica

Arnica Montana Flower

NDC Product Code 66902-778

NDC 66902-778-26

Package Description: 1 TUBE in 1 CARTON > 73 g in 1 TUBE

NDC Product Information

Cvs Arnica with NDC 66902-778 is a a human over the counter drug product labeled by Natural Essentials, Inc.. The generic name of Cvs Arnica is arnica montana flower. The product's dosage form is gel and is administered via topical form.

Labeler Name: Natural Essentials, 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.

Cvs Arnica 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.

  • ARNICA MONTANA FLOWER 1 [hp_X]/73g

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.

  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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: Natural Essentials, Inc.
Labeler Code: 66902
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 01-27-2021 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: 12-31-2022 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.

Cvs Arnica 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

Arnica Montana 1X HPUS-7%

Purpose*

Bruises & Muscle Soreness

Uses*

Homeopathic remedy/medicine temporarily relieves muscle pain and stiffness due to minor injuries; reduces pain, swelling and discoloration from bruises.

Warnings

For external use only

Otc - When Using

  • When using this product
  • Use only as directed
  • Do not use with other topical products.
  • Do not bandage tightly or use a heating pad.

Stop Use And Ask A Doctor If

  • A rash or other adverse reaction occurs.
  • Symptoms worsen or persist for more than 7 days.
  • Avoid contact with eyes or mucous membranes, damaged skin or wounds.
  • Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a physician before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets, if swallowed, seek professional help and contact Poison Control Center right away.

Directions

  • Adults and Children 12 years and older:Apply & gently massage painful or bruised areas
  • Repeat as needed, no more than 4 times a day
  • Wash hands after each use with cold water
  • Store in a cool, dry area - close cap tight
  • Children under 12: Ask your doctor.

Other Information

Active ingredients are HPUS and manufactured according to homeopathic principles.

Inactive Ingredients

Caprylyl Glycol, Carbomer, PEG-8 Dimethicone, Phenoxyethanol, SDA 40-2 Alcohol, Sodium Hydroxide, Water.

* Please review the disclaimer below.