OTC Medication Information: CareOne Maximum Redness Relief Eye Drops

CAREONE MAXIMUM REDNESS RELIEF EYE DROPS- glycerin and naphazoline hydrochloride liquid
Retail Business Services, LLC

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.

Glycerin 0.5%

Naphazoline HCI 0.03%

Purposes

Lubricant

Redness reliever

Uses

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

‚Äčinstill 1 or 2 drops in the affected eye(s) up to 4 times daily.

Other information

  • store at room temperature
  • remove contact lenses before using

Inactive ingredients

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

Questions or comments?

Call 1-888-527-4276

CareOne Maximum Redness Relief Eye Drops 15mL

CareOne Maximum Redness Relief Eye Drops 15mL
(click image for full-size original)

CAREONE MAXIMUM REDNESS RELIEF EYE DROPS
glycerin, naphazoline hci liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-012
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 0.5 g in 100 mL
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.03 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
BORIC ACID
SODIUM BORATE
EDETATE DISODIUM (EDETIC ACID)
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72476-012-01 1 BOTTLE, DROPPER in 1 BOX contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (72476-012-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 01/12/2020
Labeler — Retail Business Services, LLC (967989935)
Registrant — KC Pharmaceuticals, Inc. (174450460)
Establishment
Name Address ID/FEI Operations
KC Pharmaceuticals, Inc. 174450460 manufacture (72476-012), pack (72476-012), label (72476-012)

Revised: 01/2020 Retail Business Services, LLC

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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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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