NDC 0065-0426

TEARS Naturale FORTE

Dextran 70, Glycerin, Hypromellose

TEARS Naturale FORTE is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Dextran 70; Glycerin; Hypromelloses.

Product ID0065-0426_331cd37b-5826-bd74-adb7-c13167c6fb81
NDC0065-0426
Product TypeHuman Otc Drug
Proprietary NameTEARS Naturale FORTE
Generic NameDextran 70, Glycerin, Hypromellose
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2003-01-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameAlcon Laboratories, Inc.
Substance NameDEXTRAN 70; GLYCERIN; HYPROMELLOSES
Active Ingredient Strength1 mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0065-0426-36

1 BOTTLE, DROPPER in 1 CARTON (0065-0426-36) > 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date2016-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0426-22 [00065042622]

GenTeal Tears (Moderate) SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2003-01-02
Marketing End Date2018-11-21

NDC 0065-0426-36 [00065042636]

GenTeal Tears (Moderate) SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-03-01

NDC 0065-0426-37 [00065042637]

GenTeal Tears (Moderate) SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-03-01

Drug Details

Active Ingredients

IngredientStrength
DEXTRAN 701 mg/mL

OpenFDA Data

SPL SET ID:a2992597-3490-6a5c-be45-2b6fa15e1547
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 900138
  • 1739851
  • NDC Crossover Matching brand name "TEARS Naturale FORTE" or generic name "Dextran 70, Glycerin, Hypromellose"

    NDCBrand NameGeneric Name
    0065-0426TEARS Naturale FORTEDextran 70, Glycerin, Hypromellose
    0065-5050TEARS Naturale FORTEDextran 70, Glycerin, Hypromellose
    50090-5050GenTeal Tears (Moderate)Dextran 70, Glycerin, Hypromellose
    70000-0588Sterile Gentle TearsDextran 70, Glycerin, Hypromellose

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.