OTC Medication Information: Xpect Industrial Eye Relief

XPECT INDUSTRIAL EYE RELIEF- naphazoline hydrochloride and glycerin solution/ drops
Cintas Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Glycerin 0.25%

Naphazoline HCl 0.012%

Purposes

Lubricant

Redness reliever

Uses

• relieves redness of the eye due to minor eye irritations
• for use as a protectant against further irritation or to relieve dryness of the eye
• for the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy

Ask a doctor before use if you have

narrow angle glaucoma

When using this product

• to avoid contamination, do not touch tip of container to any surface
• replace cap after using
• overuse may produce increased redness of the eye
• pupils may become enlarged temporarily

Stop use and ask a doctor if

• you experience eye pain
• you experience changes in vision
• you experience 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 (1-800-222-1222) right away.

Directions

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Other information

store at room temperature

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

Questions?

1-877-973-2811

Monday-Friday

8:00am-5:00pm

Xpect Industrial Eye Relief 15mL

XPECT INDUSTRIAL EYE RELIEF glycerin, naphazoline hcl solution/ drops

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-255 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.012 g in 100 mL GLYCERIN (GLYCERIN) GLYCERIN 0.25 g in 100 mL

Inactive Ingredients Ingredient Name Strength BORIC ACID EDETATE DISODIUM SODIUM BORATE BENZALKONIUM CHLORIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42961-255-01 1 BOTTLE, DROPPER in 1 BOX contains a BOTTLE, DROPPER 1 15 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (42961-255-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 03/01/2022

Labeler — Cintas Corporation (056481716)

Registrant — KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Operations
KC Pharmaceuticals, Inc.		174450460	manufacture (42961-255), pack (42961-255), label (42961-255)

Revised: 09/2022 Cintas Corporation