FDA.reportPublic FDA data

MOISTU-EYES

Manufacturer
BRASSICA PHARMA PRIVATE LIMITED
Effective date
2020-01-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:29

Label at a glance#

ProductMOISTU-EYES
Active ingredientPETROLATUM, MINERAL OIL
Label structure11 sections

Indications and uses

To lubricate and protect your eyes in certain eye conditions, or during or after surgery.

Dosage and administration

Pull lower lid down to form a pouch and apply a small strip of ointment to it. Repeat this treatment as often as needed or as directed by your doctor. If you get any side effects, talk to your doctor, pharmacist or nurse.

Storage and handling

Remove contact lenses before use. After use, wait 30 minutes before putting them back in. Do not use after the expiry date shown. Discard any unused product 1 month after first opening. Store below 25°C.

Label contents#

Full prescribing information#

Ingredients:

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 57.3%

Mineral Oil 42.5%

Purpose

OTC - PURPOSE SECTION

Lubricating Emollient

Uses:

INDICATIONS & USAGE SECTION

  • To lubricate and protect your eyes in certain eye conditions, or during or after surgery.

Warning

WARNINGS SECTION

  • For external use only.
  • Do not use if you are allergic to Lanolin Alcohols or any of the other ingredients of MOISTU-EYES ®.
  • May cause short-term blurring (typically 1-15 minutes upon use).

Do not drive or use machinery unless your vision is clear.

Stop use and ask a doctor if

you experience any of the following, stop use and see your doctor: eye pain, eye irritation, eye redness, eye itching, swelling of the eyelid, increased tear production, feeling there's something in your eye, hypersensitivity (allergic reaction).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach and sight of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Pull lower lid down to form a pouch and apply a small strip of ointment to it.
  • Repeat this treatment as often as needed or as directed by your doctor. If you get any side effects, talk to your doctor, pharmacist or nurse.

Other Information

STORAGE AND HANDLING SECTION

  • Remove contact lenses before use. After use, wait 30 minutes before putting them back in.
  • Do not use after the expiry date shown.
  • Discard any unused product 1 month after first opening.
  • Store below 25°C.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Lanolin Alcohols.

Question or Comments:

OTC - QUESTIONS SECTION

Call: +912228704581

SPL UNCLASSIFIED SECTION

Eye Ointment
Preservative Free

STERILE

Eye Lubricant
For External Use

Moistueyes ® is used to lubricate and protect your eyes in certain eye conditions, or during or after surgery.

Distributed by:
Amilco Ltd, Mckenzie House, Bury Street, Ruislip, HA4 7TL, UK

Manufactured by:
Brassica Pharma Private Limited,
Plot No.T-68, T-68 (PT) & T-63, M.I.D.C., Tarapur, (W), Boisar - Thane-401 502 India. (IND)

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label-3.5g-and-5glabel-3.5g-and-5g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702008mineral oil 42.5 % / petrolatum 57.3 % Ophthalmic OintmentPSN2
702008mineral oil 0.425 MG/MG / petrolatum 0.573 MG/MG Ophthalmic OintmentSCD2
702008mineral oil 42.5 % / petrolatum, white 57.3 % Ophthalmic OintmentSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72362-101-012022-01-28C16284748780-1d6a99b39-3854-a426-e053-dadaa90af4c2MOISTU-EYES ®
72362-101-022022-01-28C16284748780-1d6a99b39-3854-a426-e053-dadaa90af4c2MOISTU-EYES ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72362-101-01MOISTU-EYES3.5 g in 1 TUBEOINTMENT3.52
72362-101-01MOISTU-EYES1 in 1 CARTONOINTMENT12
72362-101-02MOISTU-EYES1 in 1 CARTONOINTMENT12
72362-101-02MOISTU-EYES5 g in 1 TUBEOINTMENT52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72362-101MOISTU-EYES (WHITE PETROLATUM, MINERAL OIL) OINTMENT [BRASSICA PHARMA PRIVATE LIMITED]2Legacy NDC, 4 package rows20200129_412b271b-7bef-45b0-8d77-c0ec20b4caf6.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72362-10172362-101-01, 72362-101-02

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
LANOLIN ALCOHOLS884C3FA9HEIACT
PETROLATUM4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPACTIB

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
9d3bcb94-c8ea-b8fe-e053-2995a90a87a5412b271b-7bef-45b0-8d77-c0ec20b4caf62020-01-28WarningsExact identifier
spl id: 9d3bcb94-c8ea-b8fe-e053-2995a90a87a5
spl set id: 412b271b-7bef-45b0-8d77-c0ec20b4caf6

Reported adverse events (FAERS/openFDA)#

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