NDC 52862-020 Health Smart Medicated Body

Menthol And Zinc Oxide

NDC Product Code 52862-020

NDC 52862-020-22

Package Description: 283 g in 1 BOTTLE

NDC Product Information

Health Smart Medicated Body with NDC 52862-020 is a a human over the counter drug product labeled by International Wholesale Inc Dba Home Smart Products. The generic name of Health Smart Medicated Body is menthol and zinc oxide. The product's dosage form is powder and is administered via topical form.

Labeler Name: International Wholesale Inc Dba Home Smart Products

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Health Smart Medicated Body 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 .15 g/100g
  • ZINC OXIDE 1 g/100g

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.

  • TALC (UNII: 7SEV7J4R1U)
  • ACACIA (UNII: 5C5403N26O)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • THYMOL (UNII: 3J50XA376E)
  • ZINC STEARATE (UNII: H92E6QA4FV)

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: International Wholesale Inc Dba Home Smart Products
Labeler Code: 52862
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: 02-27-2014 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.

Health Smart Medicated Body Product Label Images

Health Smart Medicated Body 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

Otc - Active Ingredient

Active IngredientsMenthol        0.15%Zinc Oxide      1.0%

Otc - Purpose

PurposeExternal AnalgesicSkin Protectant

Indications & Usage

  • UsesFor the temporary relief of pains and itch associated with:Minor CutsScrapesSunburnInsect BitesPrickly HeatRashesMinor BurnsMinor Skin IrritationDries the oozing of poison ivy, oak, and sumac.

Warnings

WarningsFor external use only.

Otc - When Using

When using this product avoid contact with eyes.

Otc - Ask Doctor

  • Consult a doctor and discontinue use ifcondition worsenssymptoms do not get better within 1 week or clear up and occurs again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIn case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Dosage & Administration

  • Directionsadults and children 2 years and overapply to the affected area not more than 3 or 4 times daily.children under 2 years of age: consult a physician.for best results, dry skin thoroughly before use.

Inactive Ingredient

Inactive Ingredientstalc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate.

Other

PRINCIPAL DISPLAY PANELHEALTH SMART MEDICATED BODY POWDERNET WT. 10 OZ. (283g)

* Please review the disclaimer below.