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NDC 54799-0896-10 retaine HPMC 3 mg/mL Details

retaine HPMC 3 mg/mL

retaine HPMC is a OPHTHALMIC; TOPICAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by OCuSOFT, Inc.. The primary component is HYPROMELLOSE 2910 (4000 MPA.S).

Product Information

NDC	54799-0896
Product ID	54799-896_4b9ce127-fd9c-42d9-95d1-bbce340f23b4
Associated GPIs
GCN Sequence Number	062752
GCN Sequence Number Description	hypromellose/PF DROPS 0.3 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	98526
HICL Sequence Number	034811
HICL Sequence Number Description	HYPROMELLOSE/PF
Brand/Generic	Generic
Proprietary Name	retaine HPMC
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hypromellose 2910 (4000 Mpa.s)
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC; TOPICAL
Active Ingredient Strength	3
Active Ingredient Units	mg/mL
Substance Name	HYPROMELLOSE 2910 (4000 MPA.S)
Labeler Name	OCuSOFT, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	n/a

Package

Package Images

NDC 54799-0896-10 (54799089610)

Pricing Information	N/A
NDC Package Code	54799-896-10
Billing NDC	54799089610
Package	10 mL in 1 BOTTLE, DROPPER (54799-896-10)
Marketing Start Date	2013-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba8f8be3-4641-bc28-2ec0-2ff9f4f9be9f Details

Active Ingredient Hypromellose 0.3%

Purpose Eye lubricant

Uses ▪ For the temporary releif of burning, irritation and discomfort due to dryness of the eye, or exposure to wind or sun. ▪ May be used as a protectant against further ittitation.

Warnings

▪ For use in the eyes only.

Do not use if solution changes color or becomes cloudy.

When using this product

▪ do not touch tip of container to any surface to avoid contamination.

▪ replace cap after use.

Stop use and ask a doctor if ▪ you experience eye pain, changes in vision, continued redness or irritation of the eye. ▪ the 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 immediately.

Directions

▪ Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

▪ Use only it tamper seals on top ad bottom flaps are intact.

▪ Store between 15°-30°C (59°-86°F).

▪ Keep carton for complete product information.

▪ Discard after 12 weeks.

Inactive ingredients

Citric acid, sodium citrate, sorbitol, water for injection.

Questions?

☏(800)233-5469 M-F

8:30AM-5:00PM CST

www.retainebrand.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

RETAINE HPMC

hypromellose 2910 (4000 mpa.s) solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54799-896
Route of Administration	OPHTHALMIC, TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35)	Hypromellose 2910 (4000 Mpa.s)	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Anhydrous Citric Acid (UNII: XF417D3PSL)
Sodium Citrate (UNII: 1Q73Q2JULR)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54799-896-10	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/01/2013	04/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	05/01/2013	04/30/2023

Labeler - OCuSOFT, Inc. (174939207)

Registrant - OCuSOFT, Inc. (174939207)

Revised: 7/2022

Document Id: 4b9ce127-fd9c-42d9-95d1-bbce340f23b4

Set id: ba8f8be3-4641-bc28-2ec0-2ff9f4f9be9f

Version: 3

Effective Time: 20220707