OTC Medication Information: Eye Drops AC

EYE DROPS AC- zinc sulfate and tetrahydrozoline hydrochloride solution/ drops
KC Pharmaceuticals, Inc.

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

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purposes

Tetrahydrozoline HCl…..Redness reliever

Zinc sulfate……………Astringent

Use

■ for temporary relief of discomfort and redness of the eye due to minor eye irritations

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

When using this product

■ pupils may become enlarged temporarily

■ to avoid contamination, do not touch tip of container to any surface. Replace cap after using.

■ if solution changes color or becomes cloudy, do not use

■ overuse may produce increased redness of the eye

■ remove contact lens before using

Stop use and ask a doctor if you experience

■ eye pain

■ changes in vision

■ continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

If pregnant or breast-feeding , ask a health professional before use.

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 15°-30°C (59°-86°F)

Inactive ingredients

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

Carton
(click image for full-size original)

EYE DROPS AC
tetrahydrozoline hydrochloride, zinc sulfate solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55651-024
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC SULFATE (ZINC CATION) ZINC SULFATE 2.5 mg in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
WATER
SODIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM (EDETIC ACID)
SODIUM CITRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55651-024-01 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (55651-024-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 10/23/2003
Labeler — KC Pharmaceuticals, Inc. (174450460)
Establishment
Name Address ID/FEI Operations
KC Pharmaceuticals, Inc. 174450460 manufacture (55651-024), pack (55651-024), label (55651-024)

Revised: 01/2021 KC Pharmaceuticals, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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