Search by Drug Name or NDC

NDC 47682-0193-83 Medi-First Lubricant Eye Drops 0.5 g/100mL Details

Medi-First Lubricant Eye Drops 0.5 g/100mL

Medi-First Lubricant Eye Drops is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. The primary component is CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM.

Product Information

NDC	47682-0193
Product ID	47682-193_ebcd4610-1a70-bf75-e053-2995a90ac403
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	Medi-First Lubricant Eye Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	Carboxymethylcellulose sodium
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	0.5
Active Ingredient Units	g/100mL
Substance Name	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Labeler Name	Unifirst First Aid Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 47682-0193-83 (47682019383)

Pricing Information	N/A
NDC Package Code	47682-193-83
Billing NDC	47682019383
Package	30 AMPULE in 1 BOX (47682-193-83) / .4 mL in 1 AMPULE
Marketing Start Date	2020-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a4e651cc-adf0-af9e-e053-2995a90ace5a Details

Drug Facts

Active Ingredient

Carboxymethylcellulose sodium 0.5%

Purpose

Eye lubricant

Uses

for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
for use a protectant against further irritation

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy

When using this product

do not reuse
once opened, discard
to avoid contamination, do not touch tip of container to any surface
do not touch unit-dose tip to eye

Stop use and aska doctor if

you experience eye pain
changes in vision occur
redness or irritation of the eye continues
redness or irritation of the eye worsens or persists for more than 72 hours

SPL UNCLASSIFIED SECTION

Keep out od reach of children.

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

Directions

to open, twist and pull tab to remove
instill 1 or 2 drops in the affected eye(s) as needed and discard container
if used for post-operative (e.g.,LASIK) dryness and discomfort, follow your eye doctor's instructions

Other information

store at 59º-77ºF (15º-25ºC)
use only if single use container is intact
use before expiration date marked on container
RETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive ingredients

calcium chloride, **hydrochloric acid, magmesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate

** May contain these ingredients to adjust pH

Questions or comments?

Call 1-800-634-7680

Medi-First Lubricant Eye Drops Label

NDC 47682-193-83

*Compare to the active ingredient in Refresh Plus®

Medi-First®

Preservative-free

Lubricant Eye Drops

Carboxymethylcellulose Sodium 0.5%

Eye Lubricant

Immediate, long-lasting relief for dry, irritated eyes

Sterile

30 Single-Use Containers

0.01 fl oz (0.4 mL) each

INGREDIENTS AND APPEARANCE

MEDI-FIRST LUBRICANT EYE DROPS

carboxymethylcellulose sodium solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-193
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM LACTATE (UNII: TU7HW0W0QT)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
HYDROCHLORIC ACID (UNII: QTT17582CB)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47682-193-83	30 in 1 BOX	09/01/2020
1		0.4 mL in 1 AMPULE; 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	09/01/2020

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 10/2022

Document Id: ebcd4610-1a70-bf75-e053-2995a90ac403

Set id: a4e651cc-adf0-af9e-e053-2995a90ace5a

Version: 3

Effective Time: 20221024