Label: SUAVEAR solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 13709-233-01 - Packager: NeilMed Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 9, 2016
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- Official Label (Printer Friendly)
- SuavEar
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DOSAGE & ADMINISTRATION
For use in the ear only.
Tilt head sideways. Place 5 to 10 drops in the ear, making sure that the tip of the applicator does not enter the ear canal. Keep drops in the ear for several minutes, either by using the included ear plugs or keeping the head tilted to the side. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the enclosed soft silicone bulb. Use twice daily for up to four days, or as directed by the doctor.
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Warnings
Ask a doctor before use if
- you have ear drainage or discharge
- Ear pain
- Irritation or rash in the ear
- Dizziness
- An injury or perforation (hole) in the eardrum
- Recently had ear surgery
Whe using this product avoid contact with the eyes.
Stop use and ask a doctor if
- You need to use it for more than 3 days in a row.
- List of inactive ingredients
- Ear canal cleaning
- Purpose
- Keep out of reach of children.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUAVEAR
suavear solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13709-233 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 65 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) OXYQUINOLINE (UNII: 5UTX5635HP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13709-233-01 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/09/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/09/2016 Labeler - NeilMed Pharmaceuticals Inc. (783557783) Establishment Name Address ID/FEI Business Operations NeilMed Pharmaceuticals, Inc. 799295915 manufacture(13709-233)