NDC 50066-913 Tukol Max Action

Oxymetazoline Hcl

NDC Product Code 50066-913

NDC 50066-913-05

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 15 mL in 1 BOTTLE, SPRAY

NDC Product Information

Tukol Max Action with NDC 50066-913 is a a human over the counter drug product labeled by Genomma Lab Usa, Inc.. The generic name of Tukol Max Action is oxymetazoline hcl. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Genomma Lab Usa, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Tukol Max Action 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.

  • OXYMETAZOLINE HYDROCHLORIDE .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.

  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • POVIDONE K30 (UNII: U725QWY32X)
  • WATER (UNII: 059QF0KO0R)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Genomma Lab Usa, Inc.
Labeler Code: 50066
FDA Application Number: part341 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: 05-06-2021 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.

Tukol Max Action 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

Otc - Active Ingredient

Active Ingredient.................................................
PurposeOxymetazoline hydrochloride 0.05%.....................Nasal decongestant

Otc - Purpose

  • Usestemporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergiestemporarily relieves sinus congestion and pressureshrinks swollen nasal membranes so you can breathe more freely

Warnings

WarningsAsk a doctor before use if you have • heart disease
• high blood pressure • thyroid disease • diabetes• trouble urinating due to an enlarged prostrate gland

Otc - When Using

  • When using this productdo not use more than directeddo not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.temporary discomfort such as burning, stinging, sneezing, or​ an increase in nasal dischare may occuruse of this container by more than one person may spread infection

Otc - Stop Use

Stop use and ask a doctor if symptoms persist.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional
before use.

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.

Indications & Usage

Directions• adults and children 6 to under 12 years of
age (with adult supervision): 2 or 3 sprays in each nostril notmore often than every 10 to 12 hours. Do not exceed 2 dosesin any 24-hour period. • children under 6 years of age:consult a doctor • shake well before use. Remove safetyseal. To open, rotate cap to align the marks. Squeeze cap onboth sides in a counter-clockwise turn and pull off to remove.To spray, remove clamp and hold bottle with thumb at baseand nozzle between first and second fingers. Without tilting thehead, insert nozzle into nostril. Fully depress rim with a firm,even stroke and sniff deeply. Wipe nozzle clean after use andsnap cap onto bottle.

Storage And Handling

Other information •
store at room temperature 20-25ºC
(68-77ºF) • keep carton for full labeling

Inactive Ingredient

Inactive ingredients benzalkonium chloride, benzyl
alcohol, edetate disodium, polyethylene glycol 1500, povidonek30, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate

Dosage & Administration

Made in ChinaDistributed by: Genomma Lab USA Inc.,
Houston, TX 77027

* Please review the disclaimer below.