Bouton Eye Wash: Package Insert and Label Information

BOUTON EYE WASH- water rinse
Aaxis Pacific

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 Purpose:

Purified water USP98.6%……………………………………..Eye Wash

Purpose:

Eye Wash

Uses: For flushing/irrigating the eyes to remove loose foreign material, air pollutants, chlorinated water and to refresh irritated or tired eyes.

Warning:

For external use only

Do Not Use:
  • for injection
  • with contact lenses
  • if solution changes color or gets cloudy
  • if eye is lacerated or object is embedded
  • if twist top is broken or missing

Stop use and consult a doctor if you have:
  • changes in vision
  • continued redness in or near the eyes
  • eye pain
  • if condition worsens or persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • twist top to open
  • flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
  • discard bottle after use, single use only

Other Information:

Store out of direct sunlight between 15 degrees C and 30 degrees C (59 degrees F — 86 degrees F)

Inactive Ingredients:

Potassium phosphate monobasic, sodium chloride USP, sodium hydroxide.

Questions:

800-426-1881 www.hlbouton.com eyewear@hlbouton.com

Manufactured in Singapore for H.L. Bouton Co. Wareham, Ma. 02571

image of bottle label 473ml
(click image for full-size original)

image of carton label 473ml
(click image for full-size original)

BOUTON EYE WASH
water rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68276-004
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Water (Water) Water 98.6 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68276-004-02 12 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE (68276-004-01)
1 NDC:68276-004-01 473 mL in 1 BOTTLE This package is contained within the CARTON (68276-004-02)
2 NDC:68276-004-04 12 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE (68276-004-03)
2 NDC:68276-004-03 944 mL in 1 BOTTLE This package is contained within the CARTON (68276-004-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 01/15/2010
Labeler — Aaxis Pacific (751370305)

Revised: 07/2010 Aaxis Pacific

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