Visine Red Eye Hydrating Comfort

Visine Red Eye Hydrating Comfort by

Drug Labeling and Warnings

Visine Red Eye Hydrating Comfort by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VISINE RED EYE HYDRATING COMFORT- polyethylene glycol 400, tetrahydrozoline hydrochloride liquid 
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by 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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Visine Red Eye Hydrating Comfort

Drug Facts

Active ingredients

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Purpose

Lubricant

Redness reliever

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

Warnings

For external use only.

Ask a doctor before use if you have

narrow angle glaucoma.

When using this product

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

Stop use and ask a doctor if

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

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

Other information

Store at 20° to 25°C (68° to 77°F)

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

Questions?

call toll-free 888-734-7648 or 215-273-8755 (collect)

Package Labeling:

VISINE RED EYE HYDRATING COMFORT 
polyethylene glycol 400, tetrahydrozoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BORIC ACID (UNII: R57ZHV85D4)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCINE (UNII: TE7660XO1C)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POLIXETONIUM CHLORIDE (UNII: RNW5AM67C0)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-301-06	6 in 1 BOX	08/15/2020	08/15/2020
1		1 in 1 BLISTER PACK
1		8 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	08/15/2020	08/15/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 3/2021

Document Id: bd323c59-5960-c0b7-e053-2a95a90a8ad9

34390-5

Set id: 402042d7-fd2b-470f-96e1-5fdb7703182a

Version: 2

Effective Time: 20210310