Search by Drug Name or NDC

NDC 70000-0087-01 Eyes Irritation Relief 5; 6; .5 mg/mL; mg/mL; mg/mL Details

Eyes Irritation Relief 5; 6; .5 mg/mL; mg/mL; mg/mL

Eyes Irritation Relief is a OPHTHALMIC LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. The primary component is POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming.

Related Packages: 70000-0087-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tetrahydrozoline Ophthalmic

Product Information

NDC	70000-0087
Product ID	70000-0087_c607e19d-2eb4-cb87-e053-2995a90ab785
Associated GPIs	86409903752020
GCN Sequence Number	064168
GCN Sequence Number Description	tetrahydrozoline/polyvin a/pov DROPS 0.05-0.5 % OPHTHALMIC
HIC3	Q6D
HIC3 Description	EYE VASOCONSTRICTORS (OTC ONLY)
GCN	99874
HICL Sequence Number	035694
HICL Sequence Number Description	TETRAHYDROZOLINE HCL/POLYVINYL ALCOHOL/POVIDONE
Brand/Generic	Generic
Proprietary Name	Eyes Irritation Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	OPHTHALMIC
Active Ingredient Strength	5; 6; .5
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Labeler Name	Cardinal Health, 110 dba LEADER
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70000-0087-01 (70000008701)

Pricing Information	N/A
NDC Package Code	70000-0087-1
Billing NDC	70000008701
Package	1 BOTTLE, DROPPER in 1 BOX (70000-0087-1) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-03-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bd2608c6-ffdf-352a-e053-2995a90a26a8 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Polyvinyl alcohol 0.5%

Active ingredients

Povidone 0.6%

Purpose

Lubricant

Active ingredient

Tetrahydrozoline hydrochloride 0.05%

Purpose

Redness reliever

Uses

for the temporary relief of burning & irritation due to dryness of the eye
for use as a protectant against further irritation or to relieve dryness of the eye
relieves redness of the eye due to minor eye irritations

Warnings

For external use only

Do not use if

solution changes color or becomes cloudy.

Ask a doctor before use if you have

narrow angle glaucoma.

When using this product

to avoid contamination, do not touch tip to any surface
replace cap after using
overuse may produce increased redness of the eye
pupils may become enlarged temporarily

Stop use & ask a doctor if

you experience eye pain
you experience changes in vision
you experience continued redness or irritation of the eye
the condition worsens
symptoms last for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Directions

Instill 1 to 2 drops in the affected eye(s) up to four times daily.

Other information

store at room temperature
remove contact lenses before using

Inactive ingredients

Benzalkonium Chloride, Disodium Hydrogen Phosphate Anhydrous, Disodium Edetate, Mannitol , Potassium Chloride, Purified Water, Sodium dihydrogen Phosphate Dihydrate, Sodium Chloride, Sodium Citrate , May Contain Hydrochloric Acid and/or Sodium Hydroxide to Adjust PH.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EYES IRRITATION RELIEF

polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0087
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	5 mg in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	6 mg in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROCHLORIC ACID (UNII: QTT17582CB)
MANNITOL (UNII: 3OWL53L36A)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0087-1	1 in 1 BOX	03/09/2021
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	03/09/2021

Labeler - Cardinal Health, 110 dba LEADER (063997360)

Revised: 6/2021

Document Id: c607e19d-2eb4-cb87-e053-2995a90ab785

Set id: bd2608c6-ffdf-352a-e053-2995a90a26a8

Version: 2

Effective Time: 20210630

Search by Drug Name or NDC

NDC 70000-0087-01 Eyes Irritation Relief 5; 6; .5 mg/mL; mg/mL; mg/mL Details

Eyes Irritation Relief 5; 6; .5 mg/mL; mg/mL; mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70000-0087-01 (70000008701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL bd2608c6-ffdf-352a-e053-2995a90a26a8 Details

SPL UNCLASSIFIED SECTION

Active ingredients

Active ingredients

Purpose

Active ingredient

Purpose

Uses

Warnings

Do not use if

Ask a doctor before use if you have

When using this product

Stop use & ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?