REFILL BUNDLE 8 LARGE OFFICE- water 
CMC Group, Inc.

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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Refill Bundle 8 Large Office

Eyewash 1 oz - 49687-0010
DRUG FACTS

Active ingredient

Purified Water 99.1%

Purpose

Eyewash

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

For external use only.

Do not use

if solution changes color or becomes cloudy

When using this product

• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes

Stop use and ask a doctor if

• you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

Keep out of reach of children.

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

Directions

• Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Other information

• not for use as contact lens solution

• use before expiration date marked on the bottle

• store at room temperature, 5° to 35°C (41° to 95°F)

Inactive ingredients

Benzalkonium chloride, sodium chloride

Package Labeling:

Kit4

Package Labeling:

EYE WASH

REFILL BUNDLE 8 LARGE OFFICE 
water kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0030
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49687-0030-01 in 1 KIT02/13/201810/31/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 30 mL
Part 1 of 1
EYE WASH 
water solution
Product Information
Item Code (Source)NDC:49687-0010
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER991 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49687-0010-04 in 1 KIT
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34902/13/201810/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/13/201810/31/2020
Labeler - CMC Group, Inc. (005583328)

Revised: 12/2020
Document Id: b695e1e0-afd2-fcfe-e053-2a95a90a84b1
Set id: 6620a8f3-099f-d045-e053-2a91aa0a0d94
Version: 3
Effective Time: 20201216
 
CMC Group, Inc.