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NDC 70000-0588-01 Sterile Gentle Tears 1; 2; 3 mg/mL; mg/mL; mg/mL Details

Sterile Gentle Tears 1; 2; 3 mg/mL; mg/mL; mg/mL

Sterile Gentle Tears is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH. The primary component is DEXTRAN 70; GLYCERIN; HYPROMELLOSES.

Product Information

NDC	70000-0588
Product ID	70000-0588_edf313b7-01c1-961f-e053-2995a90a59a0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sterile Gentle Tears
Proprietary Name Suffix	Leader
Non-Proprietary Name	Dextran 70, Glycerin, Hypromellose
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	1; 2; 3
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	DEXTRAN 70; GLYCERIN; HYPROMELLOSES
Labeler Name	CARDINAL HEALTH
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Intravascular Volume [PE], Non-Standardized Chemical Allergen [EPC], Osmotic Activity [MoA], Plasma Volume Expander [EPC
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70000-0588-01 (70000058801)

Pricing Information	N/A
NDC Package Code	70000-0588-1
Billing NDC	70000058801
Package	1 BOTTLE, DROPPER in 1 CARTON (70000-0588-1) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-11-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d08ab451-e8d5-28bb-e053-2995a90a4c03 Details

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Dextran 70 0.1%	Lubricant
Glycerin 0.2%	Lubricant
Hypromellose 0.3%	Lubricant

Uses

temporary relief of burning and irritation due to dryness of the eye
as a protectant against further irritation
temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Warnings

For external use only

Do not use

if this solution changes color or becomes cloudy
if you are sensitive to any ingredient in this product

When using this product

do not touch tip of container to any surface to avoid contamination
replace cap after each use

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if you experience any of the following:

you feel eye pain
changes in vision
continued redness or irritation of the eye
condition worsens or persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

put 1 or 2 drops in the affected eye(s) as needed

Other Information

store at room temperature
discard 30 days

Inactive ingredients:

boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride. sodium borate, stabilized oxychloro complex

Questions?

1-855-314-1850

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STERILE GENTLE TEARS LEADER

dextran 70, glycerin, hypromellose solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0588
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	1 mg in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
GLYCINE (UNII: TE7660XO1C)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CHLORIDE (UNII: 86Q357L16B)
SODIUM BORATE (UNII: 91MBZ8H3QO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0588-1	1 in 1 CARTON	11/11/2021
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	11/11/2021

Labeler - CARDINAL HEALTH (063997360)

Revised: 11/2022

Document Id: edf313b7-01c1-961f-e053-2995a90a59a0

Set id: d08ab451-e8d5-28bb-e053-2995a90a4c03

Version: 4

Effective Time: 20221120

Search by Drug Name or NDC

NDC 70000-0588-01 Sterile Gentle Tears 1; 2; 3 mg/mL; mg/mL; mg/mL Details

Sterile Gentle Tears 1; 2; 3 mg/mL; mg/mL; mg/mL

Product Information

Package

Package Images

NDC 70000-0588-01 (70000058801)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d08ab451-e8d5-28bb-e053-2995a90a4c03 Details

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

When using this product

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Directions

Other Information

Inactive ingredients:

Questions?

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