NDC 72254-123 Hi-drops

Naphazoline Hydrochloride And Glycerin

NDC Product Code 72254-123

NDC 72254-123-01

Package Description: 1 BOTTLE in 1 BLISTER PACK > 7 mL in 1 BOTTLE

NDC Product Information

Hi-drops with NDC 72254-123 is a a human over the counter drug product labeled by Tiki Talk Llc/hi-drops. The generic name of Hi-drops is naphazoline hydrochloride and glycerin. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Tiki Talk Llc/hi-drops

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Hi-drops 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 .1 mg/mL
  • GLYCERIN 2.5 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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • 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: Tiki Talk Llc/hi-drops
Labeler Code: 72254
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: 01-24-2019 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.

Hi-drops 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

Other

Drug Facts

Distributed by Tiki Talk LLC/Hi-Drops848 N. Sunrise Blvd. Building BCamano Island, WA 98282

Otc - Purpose

Active IngredientsPurposeGlycerin 0.25%LubricantNaphazoline HCL 0.012%Redness reliever

Uses

  • Relieves redness of the eye due to minor eye irritationstemporary relief of burning and irritation due to dryness of the eyesprotects against further irritation

Warnings

For external use only.

Otc - Do Not Use

Do not use if solution changes color or becomes cloudy.

Ask A Doctor Before Use If You Have

  • Narrow angle glaucomahigh blood pressurediabetesany eye injuries or infection

When Using This Product

  • Do not touch tip container to any surface to avoid contaminationdo not overuse as it may produce increased redness of the eye pupils may become enlarged temporarilyremove contact lenses before usingreplace cap after use

Stop Use And Ask A Doctor If

  • You experience eye pain, changes in vision, continued redness or irritation of the eyecondition worsens or persists for more than 72 hours

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

  • Instill 1 to 2 drops in the affected eye(s) up to four times daily.

Other Information

  • Store at 15°-30° C (59°-86°F)keep tightly closeduse before expiration date marked on the carton and bottleserious side effects associated with use of product may be reported to the phone number provided below

Inactive Ingredients

Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Borate.

Questions?

1-800-658-7271

* Please review the disclaimer below.

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