NDC 24765-126 Dr Varogel

Glycerin, Allantoin

NDC Product Code 24765-126

NDC CODE: 24765-126

Proprietary Name: Dr Varogel What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Glycerin, Allantoin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

  • 24765 - Pharmacal-international. Co., Ltd

NDC 24765-126-01

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

NDC Product Information

Dr Varogel with NDC 24765-126 is a a human over the counter drug product labeled by Pharmacal-international. Co., Ltd. The generic name of Dr Varogel 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.

Dr Varogel 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 10 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)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • DATE (UNII: H3O7QI5HY7)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • N-ACETYL-.ALPHA.-D-GLUCOSAMINE (UNII: T13TI5GH3D)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • FIG (UNII: TGD87RII2U)
  • LAURETH-7 (UNII: Z95S6G8201)
  • TABASCO PEPPER (UNII: J1M3NA843L)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
  • 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)
  • REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
  • FU LING (UNII: XH37TWY5O4)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
  • CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
  • CHINESE CINNAMON (UNII: WS4CQ062KM)
  • ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)
  • ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF)
  • ANGELICA GIGAS ROOT (UNII: 32766B2FHX)
  • ROSEMARY (UNII: IJ67X351P9)
  • CHAMOMILE (UNII: FGL3685T2X)
  • 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.
  • 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
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: 02-21-2020 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.

Dr Varogel Product Label Images

Dr Varogel 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 10%------------------------- 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, 1,2-HEXANEDIOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYSORBATE 80, VANILLYL BUTYL ETHER, ALCOHOL,BUTYLENE GLYCOL, FRAGRANCE, TRIETHANOLAMINE, CARBOMER, PROPYLENE GLYCOL, MENTHOL, POLYACRYLAMIDE,CAMPHOR, ACETYL GLUCOSAMINE, DIMETHYL SULFONE, C13-14 ISOPARAFFIN, ETHYLHEXYLGLYCERIN, PHOENIXDACTYLIFERA (DATE) FRUIT EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, CAPSICUM FRUTESCENS FRUIT EXTRACT, DISODIUMEDTA, LAURETH-7, CENTELLA ASIATICA EXTRACT, OPUNTIA FICUS-INDICA STEM EXTRACT, OPUNTIA COCCINELLIFERA FRUITEXTRACT, ADANSONIA DIGITATA SEED EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, POLYGONUM CUSPIDATUM ROOTEXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, SODIUM HYALURONATE, CAMELLIA SINENSIS LEAF EXTRACT,REHMANNIA GLUTINOSA ROOT EXTRACT, PORIA COCOS EXTRACT, PANAX GINSENG ROOT EXTRACT, PAEONIA ALBIFLORA ROOTEXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, ATRACTYLODES JAPONICA RHIZOMEEXTRACT, ASTRAGALUS MEMBRANACEUS ROOT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, ROSMARINUS OFFICINALIS(ROSEMARY) LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, BENZYL BENZOATE, CITRONELLOL, GERANIOL

* Please review the disclaimer below.