Label: CLEAR EYES MAXIMUM REDNESS RELIEF- naphazoline hydrochloride and glycerin liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 67172-494-01 - Packager: Prestige Brands Holdings, 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 September 24, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Active ingredients
- Purpose
- Uses
-
Warnings
For external use only.
When using this product:
- To avoid contamination, do not touch tip of container to any surface.
- Replace cap after using.
- Overuse may produce increased redness of the eye.
- Pupils may become enlarged temporarily.
- To avoid contamination, do not touch tip of container to any surface.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLEAR EYES MAXIMUM REDNESS RELIEF
naphazoline hydrochloride and glycerin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-494 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE .00015 mg in 1 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN .0025 mL in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-494-01 1 in 1 BOX 1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part349 09/01/2010 Labeler - Prestige Brands Holdings, Inc. (159655021) Establishment Name Address ID/FEI Business Operations Altaire Pharmaceuticals Inc. 786790378 MANUFACTURE