Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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GENTEAL  NIGHT-TIME PM- white petrolatum ointment 
Novartis Pharmaceutical Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Mineral oil (15%)
White petrolatum (85%)

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

  • Relieves dryness of the eye.
  • Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind or sun.
  • As a protectant against further irritation.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

  • if you are sensitive to any ingredient in this product

OTC - WHEN USING SECTION

When using this product do not touch tip of container to any surface. Replace cap after using.

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

OTHER SAFETY INFORMATION

Store between 15°- 25°C (59°-77°F).

INACTIVE INGREDIENT SECTION

anhydrous liquid lanolin

OTC - QUESTIONS SECTION

In the U.S. call toll-free 1-866-393-6336; [email protected]
Serious side effects associated with use of this product may be reported to this telephone number.
www.genteal.com

PRINCIPAL DISPLAY PANEL

NDC: 0078-0473-97

Night-time PM
Dry Eye Relief

GenTeal®
LUBRICANT EYE OINTMENT

GenTeal® Night-time PM ointment provides long-lasting relief for night-time comfort.

NIGHT-TIME OINTMENT
Long-lasting Night-time Relief

Alcon®

STERILE 3.5 g (0.12 fl oz)

Carton
GENTEAL   NIGHT-TIME PM
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0078-0473
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil0.15 g  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum0.85 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Lanolin (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0078-0473-971 in 1 CARTON12/14/200911/29/2019
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/14/200911/29/2019
Labeler - Novartis Pharmaceutical Corporation (002147023)
Establishment
NameAddressID/FEIBusiness Operations
S.A. Alcon-Couvreur N.V.370205429manufacture(0078-0473)

Revised: 6/2019
 
Novartis Pharmaceutical Corporation


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