NDC 0065-8064

GenTeal Tears Severe

Hypromellose

GenTeal Tears Severe is a Ophthalmic Gel in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Hypromellose 2910 (4000 Mpa.s).

Product ID0065-8064_c964fdd3-2f59-4404-90e1-80f30e7e2743
NDC0065-8064
Product TypeHuman Otc Drug
Proprietary NameGenTeal Tears Severe
Generic NameHypromellose
Dosage FormGel
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-12-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameAlcon Laboratories, Inc.
Substance NameHYPROMELLOSE 2910 (4000 MPA.S)
Active Ingredient Strength0 g/g
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0065-8064-01

1 TUBE in 1 CARTON (0065-8064-01) > 10 g in 1 TUBE
Marketing Start Date2019-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-8064-01 [00065806401]

GenTeal Tears Severe GEL
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2019-12-14

Drug Details

Active Ingredients

IngredientStrength
HYPROMELLOSE 2910 (4000 MPA.S).003 g/g

NDC Crossover Matching brand name "GenTeal Tears Severe" or generic name "Hypromellose"

NDCBrand NameGeneric Name
0078-0429GenTealHYPROMELLOSE
0078-0517GenTealhypromellose
0065-8064GenTeal TearsHypromellose
0536-6237Natures TearsHypromellose
10742-8194Rohto JoltHypromellose
57619-303Splash TearsHypromellose
0065-0474Systanehypromellose
77790-002VISTA Hypromellose Dry Eye Reliefhypromellose

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