REDNESS RELIEVER AND LUBRICANT- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl liquid

Redness reliever and Lubricant by

Drug Labeling and Warnings

Redness reliever and Lubricant by is a Otc medication manufactured, distributed, or labeled by Promex, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Dextran 70 0.1%

Polyethylene Glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.5%

Purpose

Lubricant

Lubricant

Lubricant

Redness reliever

Use

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

Warnings

Ask a doctor before use if you have narrow angle glaucoma

When using this product

• pupils may become enlarged temporarily
• overuse may cause more eye redness
• remove contact lenses before using
• do not use if this solution changes color or become cloudy
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens or lasts 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 immediately.

Directions

• Put 1 to 2 drops in the affected eye(s) up to 4 times daily
• children under 6 years of age:  ask a doctor
  

Other information

• store at 15-30 °C (59-86 °F)

Inactive ingredients

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

package label

Redness Reliever and Lubricant

INGREDIENTS AND APPEARANCE

REDNESS RELIEVER AND LUBRICANT 
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58988-0018
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	1 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58988-0018-1	1 in 1 BOX	12/06/2013
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/06/2013

Labeler - Promex, LLC (789974388)