Label: EAR DROPS EARWAX REMOVAL AID- carbamide peroxide liquid
Contains inactivated NDC Code(s)
NDC Code(s): 24385-955-01, 24385-955-02
- Packager: AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy)
- 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.
Updated June 28, 2013
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- Active ingredient
- ASK DOCTOR
- Stop use and ask a doctor if
- WHEN USING
- Keep out of reach of children
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 a soft rubber bulb ear syringe.
- Children under 12 years: consult a doctor.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EAR DROPS EARWAX REMOVAL AID
carbamide peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-955 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 GLYCERIN (UNII: PDC6A3C0OX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24385-955-01 1 in 1 CARTON 1 NDC:24385-955-02 15 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 01/01/2012 Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) (007914906) Registrant - Lee Pharmaceuticals (056425432) Establishment Name Address ID/FEI Business Operations AmerisourceBergen Drug Corporation 007914906 label(24385-955) Establishment Name Address ID/FEI Business Operations Lee Pharmaceuticals 056425432 manufacture(24385-955)