Label: EARWAX REMOVAL KIT- carbamide peroxide liquid
- NDC Code(s): 41250-835-33
- Packager: Meijer Distribution Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 13, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
-
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 titled 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 a soft rubber bulb ear syringe
Children under 12 years: consult a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- Product Labels
-
INGREDIENTS AND APPEARANCE
EARWAX REMOVAL KIT
carbamide peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-835 Route of Administration TOPICAL 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-835-33 1 in 1 CARTON 11/27/2014 1 15 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 11/27/2014 Labeler - Meijer Distribution Inc. (006959555) Establishment Name Address ID/FEI Business Operations Bell Pharmaceuticals, Inc. 140653770 manufacture(41250-835)