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NDC 62011-0104-01 Eye Drops Advanced Relief 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL Details
Eye Drops Advanced Relief 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL
Eye Drops Advanced Relief is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming.
Related Packages: 62011-0104-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tetrahydrozoline Ophthalmic
Product Information
| NDC | 62011-0104 |
|---|---|
| Product ID | 62011-0104_93439cae-3d8b-2681-e053-2995a90ab3e4 |
| Associated GPIs | 86409904502020 |
| GCN Sequence Number | 050535 |
| GCN Sequence Number Description | tetrahydroz/dext 70/peg 400/pv DROPS 0.05-.1-1% OPHTHALMIC |
| HIC3 | Q6D |
| HIC3 Description | EYE VASOCONSTRICTORS (OTC ONLY) |
| GCN | 17625 |
| HICL Sequence Number | 023805 |
| HICL Sequence Number Description | TETRAHYDROZOLINE HCL/DEXTRAN 70/POLYETHYLENE GL 400/POVIDONE |
| Brand/Generic | Generic |
| Proprietary Name | Eye Drops Advanced Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tetrahydrozoline hydrochloride, polyethylene glycol 400, dextran 70, povidone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 1; 10; 10; .5 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL; mg/mL |
| Substance Name | DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE |
| Labeler Name | Strategic Sourcing Services LLC |
| Pharmaceutical Class | Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part349 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 62011-0104-01 (62011010401)
| NDC Package Code | 62011-0104-1 |
|---|---|
| Billing NDC | 62011010401 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (62011-0104-1) / 15 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2012-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.1541 |
| Pricing Unit | ML |
| Effective Date | 2023-11-22 |
| NDC Description | HM EYE DROPS ADVANCED RELIEF |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 5a6be263-ebda-45fb-aa39-138b27ef7f89 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
For external use only
When using this product
- pupils may become enlarged temporarily
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using
- if solution changes color or becomes cloudy, do not use
- overuse may product increased redness of the eye
- remove contact lens before using
Stop use and ask a doctor if you experience
- eye pain
- changes in vision
- continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| EYE DROPS ADVANCED RELIEF
tetrahydrozoline hydrochloride, polyethylene glycol 400, dextran 70, povidone solution/ drops |
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| Labeler - Strategic Sourcing Services LLC (116956644) |
| Registrant - KC Pharmaceuticals, Inc. (174450460) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| KC Pharmaceuticals, Inc. | 174450460 | manufacture(62011-0104) , pack(62011-0104) , label(62011-0104) | |
Revised: 9/2019
Document Id: 93439cae-3d8b-2681-e053-2995a90ab3e4
Set id: 5a6be263-ebda-45fb-aa39-138b27ef7f89
Version: 2
Effective Time: 20190923