Label: WATER ADDITIVE- purified water liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 64809-105-20 - Packager: Sperian Eye & Face Protection Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 21, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
-
Warnings
- For external use only
- To avoid contamination do not touch tip of container to any surface
Do not use
- in concentrated form
- while wearing contact lenses
- if solution changes color or becomes cloudy
- for injection
- in intraocular surgery
- internally
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Directions
Mix additive with potable water as follows:
- Wear protective eyewear and gloves
- Follow sanitary procedures
- Thoroughly clean portable eyewash station and rinse with potable water
- Use a clean container of sufficient capacity to mix enough solution to fill eyewash station. Solution may be mixed directly in eyewash station
- Add entire contents of the bottle to the container
- Fill the station to the manufacturer's required level and mix or agitate thoroughly
- Date station inspection
- Station should be cleaned and refilled every 120 days when using this product
- Properly dispose of empty bottles after use. D
o not reuse.
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Other information
- Do not use is seal is broken
- Do not freeze
- Do not use if eye is lacerated or object is embedded
- For use in emergency eyewash stations only
- Mix per directions
- Sperian Water Additive must not be used undiluted or in solution for any other purpose
- Do NOT add any other chemicals or materials to this solution
- Avoid contact with skin
- Store between 35
oF - 100
oF (2
oC - 38
oC)
- Inactive ingredients
- Questions?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
WATER ADDITIVE
purified water liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64809-105 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 99 mL in 100 mL Inactive Ingredients Ingredient Name Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64809-105-20 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 02/01/2012 Labeler - Sperian Eye & Face Protection Inc (013435034) Establishment Name Address ID/FEI Business Operations Sperian Eye & Face Protection Inc 013435034 manufacture(64809-105)
