NDC 24765-125 Mons

Glycerin, Allantoin

NDC Product Code 24765-125

NDC 24765-125-01

Package Description: 1 TUBE in 1 BOX > 150 g in 1 TUBE

NDC Product Information

Mons with NDC 24765-125 is a a human over the counter drug product labeled by Pharmacal-international. Co., Ltd. The generic name of Mons is glycerin, allantoin. The product's dosage form is gel and is administered via topical form.

Labeler Name: Pharmacal-international. Co., Ltd

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.

Mons 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.

  • GLYCERIN 8 g/100g
  • ALLANTOIN .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.

  • WATER (UNII: 059QF0KO0R)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
  • ALCOHOL (UNII: 3K9958V90M)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • N-ACETYLGLUCOSAMINE (UNII: V956696549)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • TROPOLONE (UNII: 7L6DL16P1T)
  • FIG (UNII: TGD87RII2U)
  • LAURETH-7 (UNII: Z95S6G8201)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • TABASCO PEPPER (UNII: J1M3NA843L)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)
  • OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
  • ADANSONIA DIGITATA SEED (UNII: 2936P60TPX)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ROSEMARY (UNII: IJ67X351P9)
  • CHAMOMILE (UNII: FGL3685T2X)
  • PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
  • ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
  • GERANIOL (UNII: L837108USY)

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: Pharmacal-international. Co., Ltd
Labeler Code: 24765
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-19-2019 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: 12-31-2020 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.

Mons 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                                       Purpose

GLYCERIN 8.0%------------------------- Skin protectantALLANTOIN 0.1%-----------------------  Skin protectant

Indication And Usage

Apply the appropriate amount before and after exercising,as if you are gently massaging your hands or vibration applications, on the areas you need,except your face.

Dosage And Administration

Apply liberally as needed, softly massage for absorption

Warnings

■ Do not use on dermatitis, damaged skin or eczema■ Stop using and ask a doctor if rash, swelling, or irritation occurs■ Keep out of reach of children■ Follow the directions

Inactive Ingrdients

WATER,CAPRYLIC/CAPRIC TRIGLYCERIDE,POLYSORBATE 80,VANILLYL BUTYL,ETHER,ALCOHOL,BUTYLENE,GLYCOL,CARBOMER,TRIETHANOLAMINE,MENTHOL,ETHYLHEXYLGLYCERIN,CAPRYLYLGLYCOL,PROPYLENE,GLYCOL,POLYACRYLAMIDE,1,2-HEXANEDIOL,DIMETHYL SULFONE,ACETYL GLUCOSAMINE,C13-14 ISOPARAFFIN,TROPOLONE,PHOENIX DACTYLIFERA (DATE) FRUIT EXTRACT,FICUS CARICA (FIG) FRUIT EXTRACT,LAURETH-7,HYDROXYACETOPHENONE,CAPSICUM FRUTESCENS FRUIT EXTRACT,CENTELLA ASIATICA EXTRACT,OPUNTIA FICUS-INDICA EXTRACT,OPUNTIA COCCINELLIFERA FRUIT EXTRACT,ADANSONIA DIGITATA SEED EXTRACT,SCUTELLARIA BAICALENSIS ROOT EXTRACT,POLYGONUM CUSPIDATUM ROOT EXTRACT,SODIUM HYALURONATE,GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT,CAMELLIA SINENSIS LEAF EXTRACT,ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT,CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT,PERILLA OCYMOIDES LEAF EXTRACT,ACORUS CALAMUS ROOT EXTRACT,DISODIUM EDTA,FRAGRANCE,BENZYL BENZOATE,CITRONELLOL,GERANIOL.

* Please review the disclaimer below.