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NDC 00363-2068-25 Walgreens Ear Wax Remover 0.065 mg/mL Details
Walgreens Ear Wax Remover 0.065 mg/mL
Walgreens Ear Wax Remover is a AURICULAR (OTIC) LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens Company. The primary component is CARBAMIDE PEROXIDE.
Product Information
NDC | 00363-2068 |
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Product ID | 0363-2068_f2819e70-f156-427f-bfd3-fa7029637c6e |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Walgreens Ear Wax Remover |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Carbamide Peroxide 6.5% |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | AURICULAR (OTIC) |
Active Ingredient Strength | 0.065 |
Active Ingredient Units | mg/mL |
Substance Name | CARBAMIDE PEROXIDE |
Labeler Name | Walgreens Company |
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 00363-2068-25 (00363206825)
NDC Package Code | 0363-2068-25 |
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Billing NDC | 00363206825 |
Package | 1 BOTTLE, DROPPER in 1 KIT (0363-2068-25) / 15 mL in 1 BOTTLE, DROPPER |
Marketing Start Date | 2014-04-28 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d3b7362b-2826-4b86-bfa3-ef302dc79143 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.
Inactive Ingredients
Other information
Principal Display Panel Bottle Label 0.5 FL OZ
Principal Display Panel Carton Label 0.5 FL OZ
Principal Display Panel Kit Label 0.5 FL OZ
INGREDIENTS AND APPEARANCE
WALGREENS EAR WAX REMOVER
carbamide peroxide 6.5% liquid |
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Labeler - Walgreens Company (008965063) |
Registrant - Sheffield Pharmaceuticals LLC (151177797) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Sheffield Pharmaceuticals LLC | 151177797 | manufacture(0363-2068) |
Revised: 1/2022
Document Id: f2819e70-f156-427f-bfd3-fa7029637c6e
Set id: d3b7362b-2826-4b86-bfa3-ef302dc79143
Version: 2
Effective Time: 20220104