Bouton by Aaxis Pacific BOUTON- water rinse

Bouton by

Drug Labeling and Warnings

Bouton by is a Otc medication manufactured, distributed, or labeled by Aaxis Pacific. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                      Purpose:

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

Purpose:

Eye Wash

INDICATIONS & USAGE

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

WARNINGS

Warning:

For external use only

DO NOT USE

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

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

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

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
  

STORAGE AND HANDLING

Other Information:

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

INACTIVE INGREDIENT

Inactive Ingredients:

Potassium phosphate monobasic, sodium chloride USP, sodium hydroxide.

QUESTIONS

Questions:

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

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOUTON   EYE WASH
water rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68276-004
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R)	Water	98.6 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68276-004-02	12 in 1 CARTON
1	NDC: 68276-004-01	473 mL in 1 BOTTLE
2	NDC: 68276-004-04	12 in 1 CARTON
2	NDC: 68276-004-03	944 mL in 1 BOTTLE

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)