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NDC 49035-0862-01 Ear Wax Removal Drops 65 mg/mL Details
Ear Wax Removal Drops 65 mg/mL
Ear Wax Removal Drops is a TOPICAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by WALMART STORES INC. The primary component is CARBAMIDE PEROXIDE.
Product Information
| NDC | 49035-0862 |
|---|---|
| Product ID | 49035-862_28736548-09b6-4dcb-acdf-00ae56a6b3f4 |
| Associated GPIs | 87400030002010 |
| GCN Sequence Number | 008120 |
| GCN Sequence Number Description | carbamide peroxide DROPS 6.5 % OTIC (EAR) |
| HIC3 | Q8R |
| HIC3 Description | EAR PREPARATIONS,EAR WAX REMOVERS |
| GCN | 34401 |
| HICL Sequence Number | 004272 |
| HICL Sequence Number Description | CARBAMIDE PEROXIDE |
| Brand/Generic | Generic |
| Proprietary Name | Ear Wax Removal Drops |
| Proprietary Name Suffix | Equate |
| Non-Proprietary Name | Carbamide Peroxide - 6.5% |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | TOPICAL |
| Active Ingredient Strength | 65 |
| Active Ingredient Units | mg/mL |
| Substance Name | CARBAMIDE PEROXIDE |
| Labeler Name | WALMART STORES INC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part344 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49035-0862-01 (49035086201)
| NDC Package Code | 49035-862-01 |
|---|---|
| Billing NDC | 49035086201 |
| Package | 1 BOTTLE, DROPPER in 1 KIT (49035-862-01) / 15 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2019-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d Details
Warnings
Stop Use and ask a Doctor if
When using this product
Keep out of the reach of children
Directions FOR USE IN THE EAR ONLY
- Adults and children over 12 years of age:
- Tilt head sideways and place 5 to 10 drops into ear.
- Tip of applicator should not enter ear canal.
- Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.
- Use twice daily for up to 4 days if needed, or as directed by a doctor.
- Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
- When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.
- Children under 12 years: consult a doctor.
Other information
Inactive ingredients
Principal Display Panel Bottle Label 0.5 FL OZ
Principal Display Panel - Carton label 0.5 FL OZ
Principal Display Panel - Carton label KIT 0.5 FL OZ
INGREDIENTS AND APPEARANCE
| EAR WAX REMOVAL DROPS
EQUATE
carbamide peroxide - 6.5% solution/ drops |
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| Labeler - WALMART STORES INC (051957769) |
| Registrant - Sheffield Pharmaceuticals LLC (151177797) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sheffield Pharmaceuticals LLC | 151177797 | manufacture(49035-862) | |
Revised: 11/2018
Document Id: 28736548-09b6-4dcb-acdf-00ae56a6b3f4
Set id: 33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d
Version: 1
Effective Time: 20181107