Label: VISCO SHIELD LUBRICANT (hypromellose 2208- 15000 mpa.s solution/ drops
- NDC Code(s): 42126-5200-0
- Packager: OASIS Medical, 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 February 2, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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Warnings
- For external use only
- To avoid contamination do not touch tip of container or applicator to any surface
- Once opened, discard
- Do not reuse
- Directions
- Questions, or comments
- Other information
- Inactive Ingredients
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PRINCIPAL DISPLAY PANEL - 2 ml Syringe Carton
VISCO SHIELD®
Topical DropsOphthalmic
Lubricant Drops- Sterile
- Preservative-free
- Single use, disposable container
CONTAINS: 6 Pouches, each Pouch containing
1 Single Use Syringe, 0.07 fl oz (2 ml)
1 Single Use Applicator TipOASIS®
OASIS® Medical, Glendora CA 91741 USA
© 2014 OASIS Medical
P940 3/2014Certain manufacturing operations have been performed by other firms
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INGREDIENTS AND APPEARANCE
VISCO SHIELD LUBRICANT
hypromellose 2208 (15000 mpa.s) solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42126-5200 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) (HYPROMELLOSE 2208 (15000 MPA.S) - UNII:Z78RG6M2N2) HYPROMELLOSE 2208 (15000 MPA.S) 17 mg in 1 mL Inactive Ingredients Ingredient Name Strength CALCIUM CHLORIDE (UNII: M4I0D6VV5M) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) HYDROCHLORIC ACID (UNII: QTT17582CB) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM ACETATE (UNII: 4550K0SC9B) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42126-5200-0 6 in 1 CARTON 06/16/2014 1 1 in 1 POUCH 1 2 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part349 06/16/2014 Labeler - OASIS Medical, Inc. (194121018) Establishment Name Address ID/FEI Business Operations OASIS Medical, Inc. 194121018 MANUFACTURE(42126-5200)