Available Formats

• Active ingredient

  Carbamide Peroxide, 6.5%

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• Purpose

  Earwax removal aid

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• Uses

  For occasional use as an aid to soften, loosen and remove excessive ear wax.

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• Warnings

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• ASK DOCTOR

  Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • irritation or rash in the ear
  • dizziness
  • and injury or perforation (hole) of the ear drum
  • recently had ear surgery

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• Stop use and ask a doctor if

  • you need to use of r more than 4 days
  • excessive ear wax remains after use of this product

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• WHEN USING

  When using this product do not get into eyes

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• Keep out of reach of children

  In case of accidental overdose or allergic reaction, get medical help or contact a Poison Control Center immediately

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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 a soft rubber bulb ear syringe.
  • Children under 12 years:  consult a doctor.

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• Other information

  • Avoid exposing bottle to excessive heat and direct sunlight.
  • Product foams on contact with earwax due to release of oxygen.  There may be an associated crackling.
  • Keep cap on bottle when not in use.
  • Lot no. and exp. date:  see label, bottom container or box.

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• Inactive ingredients

  Anhydrous Glycerin, Citric Acid, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

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• 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)

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