Label: CLEANSE RIGHT EAR WAX DROPS- ear wax drops solution/ drops
- NDC Code(s): 73117-111-05, 73117-111-10, 73117-111-15, 73117-111-70
- Packager: Blue Echo Care
- This is a repackaged label.
- Source NDC Code(s): 15579-840
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 2, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
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 INGREDIENT
-
DOSAGE & ADMINISTRATION
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.
- WARNINGS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLEANSE RIGHT EAR WAX DROPS
ear wax drops solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73117-111(NDC:15579-840) Route of Administration IRRIGATION 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 SODIUM LAURYL SULFATE (UNII: 368GB5141J) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE (UNII: 1Q73Q2JULR) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73117-111-05 1 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2022 2 NDC:73117-111-10 1 mL in 1 KIT; Type 0: Not a Combination Product 09/07/2022 3 NDC:73117-111-15 1 mL in 1 KIT; Type 0: Not a Combination Product 02/15/2023 4 NDC:73117-111-70 1 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2023 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M014 09/07/2022 Labeler - Blue Echo Care (117048847) Establishment Name Address ID/FEI Business Operations Blue Echo Care 117048847 relabel(73117-111)
