OTC Medication Information: Exchange Select Eye Drops Advanced Relief Moisturizer

EXCHANGE SELECT EYE DROPS ADVANCED RELIEF MOISTURIZER- tetrahydrozoline hydrochloride, povidone, unspecified, dextran 70 and polyethylene glycol 400 solution
Army and Air Force Exchange Service

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

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Purpose

Dextran 70….Eye lubricant

Polyethylene glycol….Eye lubricant

Povidone….Eye lubricant

Tetrahydrozoline HCl….Redness reliever

Uses

  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye

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 right away.

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Other information

Store at 15º-30ºC (59º-86ºF)º

Inactive ingredients

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

carton
(click image for full-size original)

EXCHANGE SELECT EYE DROPS ADVANCED RELIEF MOISTURIZER
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-177
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE 0.05 g in 100 mL
POVIDONE, UNSPECIFIED (POVIDONE, UNSPECIFIED) POVIDONE, UNSPECIFIED 1 g in 100 mL
DEXTRAN 70 (DEXTRAN 70) DEXTRAN 70 0.1 g in 100 mL
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 400 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BORATE
EDETATE DISODIUM (EDETIC ACID)
BENZALKONIUM CHLORIDE
BORIC ACID
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55301-177-01 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (55301-177-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 02/12/2020
Labeler — Army and Air Force Exchange Service (001695568)
Registrant — K.C. Pharmaceuticals, Inc. (174450460)
Establishment
Name Address ID/FEI Operations
K.C. Pharmaceuticals, Inc. 174450460 manufacture (55301-177), pack (55301-177), label (55301-177)

Revised: 02/2020 Army and Air Force Exchange Service

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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