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Visine Red Eye Hydrating Comfort

VISINE Red Eye Hydrating Comfort

Approved
Approval ID

dcd4164c-aa1e-4f07-ab2c-b439275629db

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 16, 2025

Manufacturers
FDA

Morning Star OTC

DUNS: 078589357

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400

PRODUCT DETAILS

NDC Product Code53209-6001
Application NumberM018
Marketing CategoryC200263
Route of AdministrationOPHTHALMIC
Effective DateJune 16, 2025
Generic NameTETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400

INGREDIENTS (15)

BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
POLIXETONIUM CHLORIDEInactive
Code: RNW5AM67C0
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
TETRAHYDROZOLINE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: 0YZT43HS7D
Classification: ACTIB
POLYETHYLENE GLYCOL 400Active
Quantity: 10 mg in 1 mL
Code: B697894SGQ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/16/2025

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/5/2020

Uses

  • for the relief of redness of the eye due to minor eye irritations
  • for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/5/2020

Inactive ingredients

ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/5/2020

Questions?

call toll-free888-734-7648or215-273-8755(collect)

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/16/2025

Repackaged by:
Morning Star OTC
145 S. Anderson St, Los Angeles,
CA 90033

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/5/2020

Active ingredients

Purpose

Polyethylene glycol 400 1%

Lubricant

Tetrahydrozoline HCl 0.05%

Redness reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 2/5/2020

Warnings

For external use only.

Ask a doctor before use if you havenarrow angle glaucoma.

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

**If pregnant or breast-feeding,**ask a health professional before use.

**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/5/2020

Directions

  • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day
  • children under 6 years of age: consult a doctor
  • children under 2 years of age: do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 2/5/2020

Other information

Store at 20° to 25°C (68° to 77°F)

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