Active Ingredient
Apraclonidine 0.125% (equivalent to apraclonidine hydrochloride 0.144%)
Brytly Solution/ Drops
FDA Label NDC 0065-8596
12 label sections · Submitted to the FDA by Alcon Laboratories, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Brytly (NDC 0065-8596). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Redness reliever
Use
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
- if you are sensitive to any ingredient in this product
Stop Use And Ask A Doctor If
- you experience eye pain, changes in vision, continued redness or irritation of the eye
- condition persists for more than 3 days or worsens
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and over:
- instill 1 drop in the affected eye(s) every 12 hours
- do not use more than 2 times daily
- remove contact lenses before use
- wait at least 10 minutes before re-inserting contact lenses after use
- if using other ophthalmic products when using this product, wait at least 5 minutes between each product
- to avoid contamination, do not touch tip of container to any surface
- replace cap after each use
- children under 12 years of age: Do not use
Other Information
- store at 2°C to 25°C (36°F to 77°F)
Inactive Ingredients
benzalkonium chloride, citric acid (monohydrate), hypromellose 2910, purified water, sodium chloride, sodium citrate (dihydrate). Hydrochloric acid and sodium hydroxide may be used to adjust pH.
Questions Or Comments?
call 1-800-757-9195 or email [email protected]
Primary Display Panel (5 Ml)
BRYTLY®
APRACLONIDINE
OPHTHALMIC SOLUTION 0.125%
REDNESS RELIEVER EYE DROPS
LASTS UP TO 12 HOURS
works in 1 minute
STERILE
5 mL (0.17 fl oz)
Alcon
Top Panel (Carton)
BRYTLY®
APRACLONIDINE
OPHTHALMIC SOLUTION 0.125%
CLINICALLY PROVEN
TO RELIEVE EYE REDNESS
Side Panel (Right of the PDP)
TAMPER EVIDENT: For your protection,
this bottle has an imprinted seal around
the neck. Do not use if seal is damaged
or missing at the time of purchase.
BRYTLY®
APRACLONIDINE
OPHTHALMIC SOLUTION 0.125%
Push down while
turning to open cap
LASTS UP TO
12 HOURS
works in 1 minute
Country of Origin:
Switzerland
NDC: 0065-8596-04
Fill Line
MANUFACTURED BY:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134
ACTUAL SIZE
300073940-1125
Bottom Panel
LOT: EXP.:
Carton Label (5mlcarton)
Primary Display Panel (5 mL)
BRYTLY®
APRACLONIDINE
OPHTHALMIC SOLUTION 0.125%
REDNESS RELIEVER
EYE DROPS
STERILE
5 mL (0.17 fl oz)
Side Panel (Right of the PDP)
TAMPER EVIDENT: For your
protection, this bottle has an
imprinted seal around the neck.
Do not use if seal is damaged or
missing at the time of purchase.
Alcon
____________________
LOT: EXP.:
300073974-1125
Side Panel (Left of the PDP)
Store at 2°C to 25°C (36°F to 77°F)
Manufactured by:
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Bottle Label (5mllabel)
Primary Display Panel (0.5 mL)
| PACKAGE NOT CHILD-RESISTANT |
BRYTLY®
APRACLONIDINE
OPHTHALMIC SOLUTION 0.125%
REDNESS RELIEVER EYE DROPS
LASTS UP TO 12 HOURS
works in 1 minute
STERILE
SAMPLE
0.5 mL (0.02 fl oz)
Alcon
Top Panel (Carton)
BRYTLY®
APRACLONIDINE
OPHTHALMIC SOLUTION 0.125%
CLINICALLY PROVEN
TO RELIEVE EYE REDNESS
Side Panel (Right of the PDP)
TAMPER EVIDENT: For your protection,
this bottle has an imprinted seal
around the neck. Do not use if seal is
damaged or missing at the time of use.
BRYTLY®
APRACLONIDINE
OPHTHALMIC SOLUTION 0.125%
LASTS UP TO
12 HOURS
works in 1 minute
Country of Origin: Switzerland
NDC: 0065-8596-06
MANUFACTURED BY:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134
300073941-1125
Bottom Panel
LOT: EXP.:
Sample Carton (Samplecarton)
Primary Display Panel (0.5 mL)
| PACKAGE NOT CHILD-RESISTANT |
BRYTLY®
APRACLONIDINE
OPHTHALMIC SOLUTION 0.125%
REDNESS RELIEVER
EYE DROPS
STERILE
0.5mL (0.02 fl oz)
Alcon
Side Panel (Right of the PDP)
SAMPLE
Store at 2°C to 25°C (36°F to 77°F). Manufactured by:
Alcon Laboratories, Inc., Fort Worth, TX 76134 USA.
TAMPER EVIDENT: For your protection, this bottle has
an imprinted seal around the neck. Do not use if seal
is damaged or missing at the time of use.
_____________________
LOT: EXP.:
300073975-1125
Sample Bottle (Samplelabel)
* Please review the disclaimer below.
