Equate Eye Drops by Aspen SVP (Pty) Ltd. Equate Eye Drops

Equate Eye Drops by

Drug Labeling and Warnings

Equate Eye Drops by is a Otc medication manufactured, distributed, or labeled by Aspen SVP (Pty) Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EQUATE EYE DROPS- tetrahyrozoline hydrochloride liquid 
Aspen SVP (Pty) Ltd.

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.

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Equate Eye Drops

Drug Facts

Active ingredient

Tetrahydrozoline Hydrochloride 0.05%

Purpose

Redness reliever

Uses

• relieves redness of the eye due to minor eye irritations

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 four times daily

Otherinformation

• store at room temperature
  
• remove contact lenses before using

Inactive ingredients

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

Questions?

1-888-287-1915

Principal Display Panel (30 mL carton)

equateTM
Redness Reliever
Tetrahydrozoline HCl

equateTM
Compare to Visine® Original Formula

                     Active Ingredient

Redness

Reliever

Tetrahydrozoline HCl

ORIGINAL

Eye Drops

Sterile
1 FL OZ (30 mL)

Principal Display Panel (15 ml Carton)

equateTM
Redness Reliever
Tetrahydrozoline HCl

equateTM
Compare to Visine® Original Formula

                  Active Ingredient

Redness

Reliever

Tetrahydrozoline HCl

ORIGINAL

Eye Drops

Sterile

0.5 FL OZ (15 mL)

EQUATE EYE DROPS 
tetrahyrozoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45052-1010
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45052-1010-1	1 in 1 BOX	02/11/2013
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 45052-1010-2	1 in 1 BOX	02/11/2013
2		30 mL in 1 BOTTLE, DROPPER; 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	02/11/2013

Labeler - Aspen SVP (Pty) Ltd. (569162139)

Establishment
Name	Address	ID/FEI	Business Operations
Aspen SVP (Pty) Ltd.		569162139	manufacture(45052-1010) , analysis(45052-1010) , pack(45052-1010) , sterilize(45052-1010)

Revised: 12/2020

Document Id: 0ef1b441-ed95-46f1-b1c0-5d03c726b299

34390-5

Set id: 406221f5-863c-4806-bcfb-b9c11128e0c5

Version: 1

Effective Time: 20201229