FDA.reportPublic FDA data

Dorama Dry Aid Eye Drops

Manufacturer
Sato Pharmaceutical Co., Ltd.
Effective date
2024-04-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:04:41

Label at a glance#

ProductDorama Dry Aid Eye Drops
Active ingredientPROPYLENE GLYCOL, POVIDONE
Label structure8 sections

Indications and uses

temporarily relieves burning and irritation due to dryness of the eye protects against further irritation or to relieve dryness of the eye

Dosage and administration

put 1 or 2 drops in the affected eye(s) as needed tightly snap on cap to seal

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Povidone 0.68%

Propylene glycol 0.3%

Purpose

OTC - PURPOSE SECTION

Povidone ............... Lubricant

Propylene glycol .....Lubricant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves burning and irritation due to dryness of the eye
  • protects against further irritation or to relieve dryness of the eye

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

To avoid contamination

  • do not touch tip of container to any surface
  • replace cap after each use
  • do not use if solution changes color or becomes cloudy
  • remove contact lenses before using

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eyes lasts
  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • put 1 or 2 drops in the affected eye(s) as needed
  • tightly snap on cap to seal

Other information

OTHER SAFETY INFORMATION

  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, calcium chloride, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium chloride.

Box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box labelBox label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-503DORAMA DRY AID EYE DROPS (POVIDONE, PROPYLENE GLYCOL) SOLUTION [SATO PHARMACEUTICAL CO., LTD.]3Legacy NDC20240424_d58650fd-9c6b-3400-e053-2a95a90a3d4c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-50349873-503-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
SODIUM BORATE91MBZ8H3QOIACT
POVIDONEFZ989GH94EACTIB
LEVOMENTHOLBZ1R15MTK7IACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
BORIC ACIDR57ZHV85D4IACT

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
16af0b0e-aba3-9c6f-e063-6394a90ad5c0d58650fd-9c6b-3400-e053-2a95a90a3d4c2024-04-17WarningsExact identifier
spl id: 16af0b0e-aba3-9c6f-e063-6394a90ad5c0
spl set id: d58650fd-9c6b-3400-e053-2a95a90a3d4c

Reported adverse events (FAERS/openFDA)#

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