Redness reliever and Lubricant
- Product NDC
- 58988-0018
- 11-digit product format
- 589880018
- Labeler code
- 58988
- Product ID
- 58988-0018_e3575286-2db0-d528-e053-2a95a90a19a8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
- Dosage form
- LIQUID
- Route
- OPHTHALMIC
- Labeler
- Promex, LLC
- Application
- part349
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2013-12-06
- Marketing end
- 0000-00-00
- Substance
- DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
- Active strength
- 1 mg/mL; mg/mL; mg/mL; mg/mL
- Pharmacologic classes
- Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTRAN 70 | ACTIVE INGREDIENT | 7SA290YK68 | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| POLYETHYLENE GLYCOL 400 | ACTIVE INGREDIENT | B697894SGQ | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| POVIDONE | ACTIVE INGREDIENT | FZ989GH94E | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| TETRAHYDROZOLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0YZT43HS7D | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| DEXTRAN 70 | ACTIVE MOIETY | 7SA290YK68 | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| POLYETHYLENE GLYCOL 400 | ACTIVE MOIETY | B697894SGQ | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| POVIDONE | ACTIVE MOIETY | FZ989GH94E | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| TETRAHYDROZOLINE | ACTIVE MOIETY | S9U025Y077 | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| SODIUM BORATE | INACTIVE INGREDIENT | 91MBZ8H3QO | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | REDNESS RELIEVER AND LUBRICANT (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PROMEX, LLC] | 2 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58988-0018-1 | 58988001801 | 1 BOTTLE in 1 BOX (58988-0018-1) > 15 mL in 1 BOTTLE | 1 bottle | 2013-12-06 | 0000-00-00 | No | No | Current |