NDC 49035-673 Equate Arnica Pain Relieving

Arnica Montana Whole

NDC Product Code 49035-673

NDC 49035-673-01

Package Description: 1 CYLINDER in 1 CARTON > 74 g in 1 CYLINDER

NDC Product Information

Equate Arnica Pain Relieving with NDC 49035-673 is a a human over the counter drug product labeled by Walmart, Inc.. The generic name of Equate Arnica Pain Relieving is arnica montana whole. The product's dosage form is gel and is administered via topical form.

Labeler Name: Walmart, 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.

Equate Arnica Pain Relieving 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 WHOLE 70 mg/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.

  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • CAPSAICIN (UNII: S07O44R1ZM)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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.
  • 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: Walmart, Inc.
Labeler Code: 49035
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: 04-30-2020 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.

Equate Arnica Pain Relieving Product Label Images

Equate Arnica Pain Relieving 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

DISTRIBUTED BY: Walmart Inc.,Bentonville, AR 72716† These uses have not been evaluated by the Food and Drug Administration.‡ X is the symbol for the homeopathic dilution 10:1 ** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredient‡

Arnica Montana 1X HPUS 7%The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Purpose**

Relieve muscle pain and stiffness, swelling from injuries, discoloration from bruises

Uses**

  • According to homeopathic principles, the active ingredient in this product temporarily relieves minor symptoms such as:♦bruising and swelling♦sprains♦backaches♦muscular aches and pains♦strains♦stiffness

Warnings

  • For external use only. Do not use on damaged skin, open wounds, or mucous membranes. Test on a small patch of skin before applying generously.♦According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).♦Avoid contact with eyes.♦Do not use if you are allergic to Arnica montana (Asteracea flower) or any of this product's inactive ingredients.♦Do not bandage tightly or use with a heating pad.♦Do not use with heating pads or other heating devices.♦If conditions worsen or if symptoms persist for more than 72 hours or clear up and occur again within a few days, discontinue use of this product and consult a physician.

When Using This Product

  • ♦use only as directed♦avoid contact with eyes and mucous membranes♦if redness is present, discontinue use and consult a doctor♦if skin irritation occurs, discontinue use♦a transient burning sensation may occur upon application but generally disappears in several days.

Flammable

  • ♦keep away from fire or flame

Otc - Pregnancy Or Breast Feeding

If pregnant, trying to get 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.

Directions

  • For adults and children 2 years of age and older:♦Apply a thin layer to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.

Other Information

  • ♦Active ingredients are manufactured according to homeopathic principles.♦Store at room temperature

Inactive Ingredients

Alcohol denat., capsaicin, carbomer, glycerin, sodium hydroxide, water.

* Please review the disclaimer below.