Label: DELUXE EAR WASH SYSTEM- carbamide peroxide kit
- NDC Code(s): 0363-2231-10, 0363-2232-15
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 25, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
-
Warnings
For use in the ear only
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) of the ear drum
- recently had ear surgery
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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 wax remaining after treatment may be removed by gently flushing the ear with warm water, using the Deluxe Ear Washer
- Children Under 12 years:consult a doctor
- Other information
- Inactive ingredients
- Questions?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
DELUXE EAR WASH SYSTEM
carbamide peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2231 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-2231-10 1 in 1 KIT 03/26/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 15 mL Part 1 of 1 EAR WAX REMOVAL AID DROPS
carbamide peroxide solution/ dropsProduct Information Item Code (Source) NDC:0363-2232 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-2232-15 1 in 1 BOX 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M014 03/25/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M014 03/26/2024 Labeler - Walgreens (008965063)