FDA.reportPublic FDA data

NOVEHA NIGHTTIME

Manufacturer
Bullet Point LLC
Effective date
2026-03-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:51:20

Label at a glance#

ProductNOVEHA NIGHTTIME
Active ingredientLIGHT MINERAL OIL, WHITE PETROLATUM
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

White Petrolatum USP 91.7%

Light Mineral Oil NF 1.4%

INACTIVE INGREDIENT SECTION

Inactive Ingredient

Lanolin USP 6.9%

OTC - PURPOSE SECTION

Purpose: Active Ingredient

White Petrolatum USP 91.7% . . . . . .Purpose: Eye Protectant

Light Mineral Oil NF 1.4% . . . . . . . . .Purpose: Lubricant

WARNINGS SECTION

Warnings

For use in the eye

INDICATIONS & USAGE SECTION

Uses:

  • For temporary relief of burning and irritation due to dryness of the eye.
  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye

When using this product

  • Do not touch tip of container to any surface to avoid contamination.
  • Replace cap after use

OTC - ASK DOCTOR SECTION

Stop use and ask a Doctor if

  • Eye pain occurs
  • Changes in vision occur
  • Redness or irritation persists
  • Condition worsens or lasts more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Pull down the lower lid of the affected eye
  • Apply a small amount (about 1⁄4 inch) of ointment inside the eyelid

OTHER SAFETY INFORMATION

Other Information:

Store at 46°–80°F (8°–27°C)

Do not use if the tamper-evident seal is broken or missing

OTC - QUESTIONS SECTION

Questions?


support@noveha.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-135060643132884GTIN-13: 5060643132884
EAN-13: 5060643132884
GTIN storage (14 digits): 05060643132884		NOVEHA OINTMENT LABEL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84008-004-02NOVEHA NIGHTTIME1 in 1 BOXGEL12
84008-004-02NOVEHA NIGHTTIME10 g in 1 TUBEGEL102

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84008-00484008-004-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPACTIB
WHITE PETROLATUMB6E5W8RQJ4ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NOVEHA NIGHTTIMEWHITE PETROLATUMBullet Point LLC4da24578-e98b-8ce1-e063-6294a90a8bf62026-03-24WarningsExact identifier
ndc (package): 84008-004-02
ndc (product): 84008-004
ndc11 (package): 84008000402
spl id: 4dc9e07d-8f98-c05b-e063-6394a90a5b3f
spl set id: 4da24578-e98b-8ce1-e063-6294a90a8bf6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.