NDC 10742-8141 Rohto Cool Relief
Naphazoline Hydrochloride, Polysorbate 80 Liquid Ophthalmic
NDC Product Code 10742-8141
Proprietary Name: Rohto Cool Relief 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: Naphazoline Hydrochloride, Polysorbate 80 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 InformationThe 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 as naphazoline hydrochloride - redness relieverpolysorbate 80 - lubricant
NDC Code Structure
- 10742 - The Mentholatum Company
- 10742-8141 - Rohto
NDC 10742-8141-1
Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 13 mL in 1 BOTTLE, WITH APPLICATOR
NDC Product Information
Rohto Cool Relief with NDC 10742-8141 is a human over the counter drug product labeled by The Mentholatum Company. The generic name of Rohto Cool Relief is naphazoline hydrochloride, polysorbate 80. The product's dosage form is liquid and is administered via ophthalmic form.
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.
Rohto Cool Relief 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.
RxNorm Crosswalk
What is RxNorm?RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.
The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:
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.
- ALCOHOL (UNII: 3K9958V90M)
- BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
- BORIC ACID (UNII: R57ZHV85D4)
- CHLOROBUTANOL (UNII: HM4YQM8WRC)
- EDETATE DISODIUM (UNII: 7FLD91C86K)
- MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
- WATER (UNII: 059QF0KO0R)
- SODIUM BORATE (UNII: 91MBZ8H3QO)
Administration Route(s)
What are the Administration Route(s)?The translation of the route code submitted by the firm, indicating route of administration.
- Ophthalmic - Administration to the external eye.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: The Mentholatum Company
Labeler Code: 10742
FDA Application Number: part349 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-21-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
* Please review the disclaimer below.
Rohto Cool Relief Product Label Images
Rohto Cool Relief 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
- Purpose
- Uses
- Warnings
- Ask A Doctor Before Use If You Have
- When Using This Product
- Stop Use And Ask A Doctor If
- Keep Out Of Reach Of Children.
- Directions
- Inactive Ingredients
- Questions?
Active Ingredients
Naphazoline hydrochloride 0.012%Polysorbate 80 0.2%
Purpose
Naphazoline hydrochloride - Redness relieverPolysorbate 80 - Lubricant
Uses
- •relieves redness of the eye due to minor eye irritations •for use as a lubricant to prevent further irritation or to relieve dryness of the eye •for protection against further irritation
Warnings
For external use only
Ask A Doctor Before Use If You Have
Narrow angle glaucoma
When Using This Product
- •do not touch tip of container to any surface to avoid contamination •replace cap after each use •do not use if solution changes color or becomes cloudy •overuse may cause more eye redness •pupils may become enlarged temporarily •remove contact lenses before using
Stop Use And Ask A Doctor If
- •you feel eye pain •changes in vision occur •redness or irritation of the eyes lasts •condition worsens or lasts more than 72 hours
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- •put 1 or 2 drops in the affected eye(s) up to 4 times daily •tightly snap on cap to sealOther information •do not store above 25°C (77°F)
Inactive Ingredients
Alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified water, sodium borate
Questions?
1-877-636-2677 MON-FRI 9 AM - 5 PM (EST)
* Please review the disclaimer below.