Pure Eyes® Sterile Eyes

Pure Eyes® Sterile Eyes

Drug Labeling and Warnings

Drug Details

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PURE EYES STERILE EYES- naphazoline hydrochloride and glycerin solution/ drops 
SAMSON PHARMACEUTICAL

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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Pure Eyes® Sterile Eyes

DRUG FACT

ACTIVE INGREDIENTSPURPOSE
Naphazoline HCL 0.01%Redness reliever
Glycerin 0.25%Lubricant

Uses

  • ♦ Relieve redness of the eye due to minor irritation
  • ♦ Temporary relief of burning and irritation due to dryness of the eye
  • ♦ Protects against further irritation

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

  • ♦ Do not touch tip of container to any surface to avoid contamination
  • ♦ Do not overuse as it may products increased redness of the eye
  • ♦ Pupils may be come enlarged temporarily
  • ♦ Remove contact lenses before using
  • ♦ Replace cap after use

Stop use and ask a doctor if

  • ♦ You experience eye pain, changes in vision, continued redness or irritation of the eyes
  • ♦ Conditions worsens or persists for more than 72 hours

Keep put of reach of children. Id swallowed, get medical help or contact a Poison Control Center 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)
  • ♦ Keep tightly closed
  • ♦ Use before expiration date marked on the carton and bottle
  • ♦ Serious side effect associated with use of the product may be reported to the phone number provided below

Inactive ingredients

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

Question?

1-888-995-9935

Manufactured by:
Samson Pharmaceutical
Commerce, CA 90040
Made in USA

PRINCIPAL DISPLAY PANEL - 7 mL Bottle Blister Pack

POCKET SIZE

MAXIMUM
REDNESS RELIEF

Pure
Eyes®

STERILE
EYE DROPS

  • Relieves
  • Protects
  • Soothes
  • Moisturizes

Made in the U.S.A.

0.24 FL OZ (7ML)

Principal Display Panel - 7 mL Bottle Blister Pack
PURE EYES STERILE EYES 
naphazoline hydrochloride and glycerin solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 20146-7000
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride0.1 mg  in 1 mL
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride (UNII: F5UM2KM3W7)  
boric acid (UNII: R57ZHV85D4)  
edetate disodium (UNII: 7FLD91C86K)  
water (UNII: 059QF0KO0R)  
sodium borate (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 20146-7000-11 in 1 BLISTER PACK
17 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34901/01/2015
Labeler - SAMSON PHARMACEUTICAL (088169581)
Establishment
NameAddressID/FEIBusiness Operations
SAMSON PHARMACEUTICAL088169581MANUFACTURE(20146-7000)

Revised: 6/2015
 
SAMSON PHARMACEUTICAL


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