NDC 67492-105 Resinol
Petrolatum And Resorcinol
NDC Product Code 67492-105
Proprietary Name: Resinol 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: Petrolatum And Resorcinol 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.
NDC Code Structure
- 67492 - Resical, Inc.
- 67492-105 - Resinol
NDC 67492-105-11
Package Description: 35.4 g in 1 JAR
NDC 67492-105-13
Package Description: 25.5 g in 1 JAR
NDC 67492-105-14
Package Description: 85.1 g in 1 JAR
NDC Product Information
Resinol with NDC 67492-105 is a a human over the counter drug product labeled by Resical, Inc.. The generic name of Resinol is petrolatum and resorcinol. The product's dosage form is ointment and is administered via topical form.
Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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.
Resinol 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.
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.
- STARCH, CORN (UNII: O8232NY3SJ)
- LANOLIN (UNII: 7EV65EAW6H)
- ZINC OXIDE (UNII: SOI2LOH54Z)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
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: Resical, Inc.
Labeler Code: 67492
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: 06-29-2002 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’.
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Resinol Product Label Images
Resinol 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 Ingredients
- Otc - Purpose
- Warnings
- Do Not Use On
- When Using This Product
- Stop Use And Ask A Doctor If
- Otc - Keep Out Of Reach Of Children
- Directions
- Inactive Ingredients
- Other
Active Ingredients
Petrolatum 55%, Resorcinol 2%
Otc - Purpose
- Temporarily protects minor cutsscrapesburnstemporarily relieves pain and itching associated with minor skin irritationsminor burnssunburnminor cutsscrapesinsect bitesrashes due to poison ivy, oak, and sumac
Warnings
For external use only
Do Not Use On
- Deep or puncture woundsanimal bitesserious burns
When Using This Product
- Do not get into eyesdo not apply over large areas of the body
Stop Use And Ask A Doctor If
- Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 2 years and over: apply to affected area not more than 3 to 4 times dailychildren under 2 years: ask a doctor
Inactive Ingredients
Calamine, corn starch, lanolin, zinc oxide
Other
Distributed by: ResiCal, Inc.Orchard Park, NY 14127
* Please review the disclaimer below.