NDC 81488-002 Mineffect Skin Protectant

Alumina, Calcarea Silicata, Magnesia Sulphurica, Silicea, Sulphur, Titanium Metallicum, Zincum Metallicum

NDC Product Information

Mineffect Skin Protectant with NDC 81488-002 is a a human over the counter drug product labeled by Kadesh Incoporation Co,ltd. The generic name of Mineffect Skin Protectant is alumina, calcarea silicata, magnesia sulphurica, silicea, sulphur, titanium metallicum, zincum metallicum. The product's dosage form is spray and is administered via topical form.

Labeler Name: Kadesh Incoporation Co,ltd

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Mineffect Skin Protectant 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.

  • ALUMINUM OXIDE 7 [hp_X]/118mL
  • CALCIUM SILICATE 6 [hp_X]/118mL
  • MAGNESIUM SULFATE HEPTAHYDRATE 7 [hp_X]/118mL
  • SILICON DIOXIDE 4 [hp_X]/118mL
  • SULFUR 4 [hp_X]/118mL
  • TITANIUM 7 [hp_X]/118mL
  • ZINC 8 [hp_X]/118mL

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.

  • KAOLIN (UNII: 24H4NWX5CO)
  • CEROUS OXALATE NONAHYDRATE (UNII: 0UV74P3R0J)
  • IRON (UNII: E1UOL152H7)
  • FERRIC CHLORIDE HEXAHYDRATE (UNII: 0I2XIN602U)
  • FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7)
  • POTASSIUM SILICATE (UNII: J86L1GUL6K)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM NITRATE (UNII: 8M4L3H2ZVZ)
  • PHOSPHORUS (UNII: 27YLU75U4W)
  • 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: Kadesh Incoporation Co,ltd
Labeler Code: 81488
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: 02-01-2021 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.

Mineffect Skin Protectant Product Label Images

Mineffect Skin Protectant 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

Alumina 7X HPUSCalcarea Silicata 6X HPUSCalcarea Silicata 5X HPUSMagnesia Sulphurica 7X HPUSSilicea 4X HPUSSulphur 4X HPUSTitanium Metallicum 7X HPUSZincum Metallicum 8X HPUSThe letters HPUS indicate that this ingredients is officially included in the Homeopathic pharmacopoeia of the United States.

Purpose

Dry, Itchy SkinChaps, CracksItchy SkinItchy SkinOut-Breaks on SkinItchy Skin, EczemaEczemaEczema

Uses

• Temporarily protects and helps to relieve minor skin irritation and itching due to *rashes *eczema.• Temporarily protects minor *scratches *burns *chapped or cracked skin

Warnings

For external use onlyDo not Use *on broken skin *large area of the skinWhen using this product *Apply only to areas with acne *Do not get into eyes *Replace cap after using *Use on Mild to moderate eczemaStop use and ask a doctor *If condition worsens *If condition last more than 7days or clear up and occur again within a few days.If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Direction

• Spray as needed to affected areas, both face and body• Children under two years old, ask a doctor

Other Information

* Store at room temperature.* Tamper Evident: Do not use if neckband on bottle is broken or missing.

Inactive Ingredients

Alumina Silicata, Cerium Oxalicum, Ferrum Metallicum, Ferrum Muriaticum, Ferrum phosphoricum, Kali Silicatum, Magnesia, Natrum Muriaticum, Natrum Nitricum, Phosphorous, Distilled Water

* Please review the disclaimer below.