NDC 65112-261 Hielo Mineral

External Analgesic

NDC Product Code 65112-261

NDC 65112-261-01

Package Description: 254 g in 1 BOTTLE, PUMP

NDC Product Information

Hielo Mineral with NDC 65112-261 is a a human over the counter drug product labeled by I Shay Cosmetics Inc. The generic name of Hielo Mineral is external analgesic. The product's dosage form is liquid and is administered via topical form.

Labeler Name: I Shay Cosmetics Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Hielo Mineral 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 .02 g/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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: I Shay Cosmetics Inc
Labeler Code: 65112
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: 01-13-2021 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.

Hielo Mineral Product Label Images

Hielo Mineral 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

Menthol 2%..................... Topical AnalgesicCamphor 3%................... Topical Analgesic

Otc - Purpose

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Cooling pain relief.

Otc - Keep Out Of Reach Of Children

WARNINGS - Keep out of reach of children

Indications & Usage

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Cooling pain relief.

Inactive Ingredients

Ethanol, Water, Methyl Salicylate, Hydrogenated Castor Oil, FD&C Blue No. 1.


For external use onlyAvoid contact with eyesStop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.Do not apply to wounds or damaged skinDo not bandage tightlyIf pregnant or breast-feeding, ask a health professional before useKeep out of reach of childrenIf swallowed, get medical help or contact a poison control center right away


Adults ands children 2 years of age and older: Spray to affected area not more than 3 to 4 times daily. Leave it on.Children under 2 years of age: Consult a physician

Other Information

Store at room temperature between 15

°and 30°C (59°-86°F)

* Please review the disclaimer below.