RETAINE ALLERGY- olopatadine hydrochloride solution/ drops

Retaine Allergy by

Drug Labeling and Warnings

Retaine Allergy by is a Otc medication manufactured, distributed, or labeled by OCuSOFT INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient	Purpose
Olopatadine (0.2%)......................................	Antihistamine
(equivalent to olopatadine hydrochloride, USP 0.222%)

PURPOSE

Use

temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Warnings

For external use only

Do not use

• if solution changes color or becomes cloudy
• if you are sensitive to any ingredient in this product
• to treat contact lens related irritation

When using this product

• do not touch tip of container to any surface to avoid contamination
• remove contact lenses before use
• wait at least 10 minutes before reinserting contact lenses after use
• do not wear contact lens if your eye is red

Stop use and ask a doctor if

you experience:

• eye pain
• changes in vision
• increased redness of the eye
• itching worsens or lasts 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

■ adults and children 2 years of age and older:

• put 1 drop in the affected eye(s) once daily, no more than once per day
• if using other ophthalmic products while using this product, wait at least 5 minutes between each product
• replace cap after each use

■ children under 2 years of age:
    consult a doctor 

Other Information

• only for use in the eye
• store between 2° to 25°C (36° to 77°F)

Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride and water for injection.

Questions?

Call (800) 233-5469
M-F 8:30 AM - 5:30 PM CST or
visit www.ocusoft.com

PRINCIPAL DISPLAY PANEL

Retaine® 
NDC-54799-25 ALLERGY

OCuSOFT

EYE ALLERGY
ITCH RELIEF

ONCE DAILY

Olopatadine Hydrochloride
Ophthalmic Solution,
USP 0.2% Antihistamine

2.5 mL (0.085 fl oz)          Sterile

Only for use in the eye. Store between
2°C to 25°C (36°F to 77°F)

TAMPER EVIDENT: Do not use if ring
at bottom of cap is broken or missing
at the time of purchase

Manufactured for:
OCuSOFT Inc., Rosenberg, TX 77471
Product of India

M.L. No: G/28/1704

20041115

LOT:

EXP:

20041115

R04/24

Retaine®
ALLERGY

OCuSOFT®

Eye Allergy
Itch Relief

Olopatadine Hydrochloride
Ophthalmic Solution, USP 0.2%

Antihistamine

ONCE DAILY
Works in Minutes

Relief from Allergens:
· Pet Dander · Pollen
· Grass · Ragweed

Sterile

2.5mL (0.085 fl oz)

OCuSOFT


TAMPER EVIDENT:
Do not use if ring at bottom of
cap is broken or missing at
the time of purchase.

Original Prescription Strength

For Ages 2
and Older
30 DAY
SUPPLY

Once Daily Eye
Allergy Itch
Relief. Works in
Minutes.

Fill Line

Actual Size

OCuSOFT

Manufactured for OCuSOFT Inc.
Rosenberg, TX 77471 USA
(800) 233-5469 wwwocusoft.com
© 2024 OCuSOFT Inc.
® marks owned by OCuSOFT inc.
Product of India

777-3-96 R04/24

INGREDIENTS AND APPEARANCE

RETAINE ALLERGY 
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54799-920
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)	OLOPATADINE HYDROCHLORIDE	5 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
Povidone, Unspecified (UNII: FZ989GH94E)
Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54799-920-25	2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209420	07/05/2024

Labeler - OCuSOFT INC. (174939207)