NDC 10742-8160 Rohto Optic Glow

Naphazoline Hydrochloride, Povidone, Propylene Glycol

NDC Product Code 10742-8160

NDC 10742-8160-1

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 13 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Rohto Optic Glow with NDC 10742-8160 is a a human over the counter drug product labeled by The Mentholatum Company. The generic name of Rohto Optic Glow is naphazoline hydrochloride, povidone, propylene glycol. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: The Mentholatum Company

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 Optic Glow 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.

  • NAPHAZOLINE HYDROCHLORIDE .3 mg/mL
  • POVIDONE, UNSPECIFIED 5 mg/mL
  • PROPYLENE GLYCOL 2 mg/mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BORIC ACID (UNII: R57ZHV85D4)
  • CHLOROBUTANOL (UNII: HM4YQM8WRC)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POTASSIUM ASPARTATE (UNII: OC4598NZEQ)
  • WATER (UNII: 059QF0KO0R)
  • PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)

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: 03-26-2021 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. Values = ‘Y’ or ‘N’.

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Rohto Optic Glow Product Label Images

Rohto Optic Glow 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

Naphazoline hydrochloride 0.03%Povidone 0.5%Propylene glycol 0.2%

Purpose

Naphazoline hydrochloride - Redness relieverPovidone – LubricantPropylene glycol - Lubricant

Uses

  • •relieves redness of the eye due to minor eye irritations •temporarily relieves burning and irritation due to dryness of the eye

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 of this product may produce increased redness of the eye •pupils may become enlarged temporarily

Stop Use And Ask A Doctor If

  • •you experience 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 seal

Other Safety Information

  • •do not store above 25°C (77°F)

Inactive Ingredients

Anhydrous citric acid, boric acid, chlorobutanol, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate, sodium citrate, sodium hyaluronate

Questions?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

* Please review the disclaimer below.