Label: GENTEAL NIGHT-TIME PM- mineral oil and petrolatum ointment
- NDC Code(s): 0078-0473-97
- Packager: Novartis Pharmaceutical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- OTC - ACTIVE INGREDIENT SECTION
Mineral oil (15%)Close
White petrolatum (85%)
- OTC - PURPOSE SECTION
- 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.Close
- 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.Close
- 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.Close
- 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.Close
- OTHER SAFETY INFORMATION
Store between 15°- 25°C (59°-77°F).Close
- INACTIVE INGREDIENT SECTION
- OTC - QUESTIONS SECTION
- PRINCIPAL DISPLAY PANEL
Dry Eye Relief
LUBRICANT EYE OINTMENT
GenTeal® Night-time PM ointment provides long-lasting relief for night-time comfort.
Long-lasting Night-time Relief
STERILE 3.5 g (0.12 fl oz)
- INGREDIENTS AND APPEARANCE
GENTEAL NIGHT-TIME PM
white petrolatum ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0078-0473 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil 0.15 g in 1 g Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum 0.85 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0078-0473-97 1 in 1 CARTON 1 3.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/14/2009 Labeler - Novartis Pharmaceutical Corporation (002147023) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 807927397 MANUFACTURE(0078-0473)