Dewax

• Earwax (Cerumen) Removal:
  Soften and facilitate removal of excessive or impacted cerumen in the external auditory canal.
• Teeth Whitening:
  Used as a bleaching agent for cosmetic tooth whitening in various concentrations.
• Oral Mucosal Ulcers (Off-label):
  Occasionally used as an oral antiseptic agent to promote healing of mouth ulcers and minor oral wounds.

• Earwax Removal:
  Typically, instill 5–10 drops of carbamide peroxide 6.5% in the affected ear twice daily for up to 4 days. After application, allow the agent to remain in the ear canal for several minutes before irrigating or cleaning.
• Teeth Whitening:
  Concentrations vary from 10% to 35% carbamide peroxide in dental gels or strips. Use as per dental professional's instructions, usually daily applications for 30 minutes to several hours over 1–2 weeks.
• Administration:
• Ear: Use dropper to instill into external auditory canal.
• Oral (Whitening): Apply with custom trays or strips on teeth surfaces.
• Special Populations:
  No specific dose adjustment for elderly or renal/hepatic impairment; avoid use in infants or children under 12 without medical advice.

Carbamide peroxide decomposes upon contact with tissues, releasing hydrogen peroxide and urea. The liberated hydrogen peroxide acts as an oxidizing agent, breaking down dense cerumen by softening and emulsifying earwax. In dental applications, hydrogen peroxide penetrates enamel and dentin, releasing free radicals that oxidize pigmented molecules in the teeth, leading to bleaching and whitening effects. The urea component also helps in softening keratin debris and enhances the agent’s cerumenolytic effect.

• Absorption:
  Minimal systemic absorption when used topically in the ear canal or oral cavity.
• Distribution:
  Not applicable due to local action.
• Metabolism:
  Rapidly decomposes into hydrogen peroxide and urea; hydrogen peroxide further breaks down into water and oxygen.
• Elimination:
  Localized effect; negligible systemic elimination.

• Pregnancy:
  No established FDA pregnancy category. Topical use considered low risk, but safety in pregnancy has not been fully established; use only if clearly needed.
• Lactation:
  No data on excretion in breast milk. Topical use is generally considered safe, but caution advised.

• Primary: Cerumenolytic agent and dental bleaching agent
• Subclass: Oxidizing agent

• Known hypersensitivity to carbamide peroxide or hydrogen peroxide.
• Perforated tympanic membrane or active ear infection (for ear use).
• Open wounds or sores in the oral cavity (for dental use).
• Children under 12 years of age (unless prescribed by a healthcare professional).

• Avoid use if there is pain, irritation, or discharge from the ear canal or mouth.
• Risk of local irritation or allergic contact dermatitis.
• Do not use in the presence of tympanic membrane perforation due to risk of ototoxicity.
• Use dental bleaching agents under professional supervision to avoid enamel or mucosal damage.
• Discontinue use if persistent irritation or hypersensitivity occurs.

Common:

• Local irritation or burning sensation in ear or oral mucosa
• Ear itching or discomfort
• Mild tooth sensitivity during whitening

Serious/Rare:

• Allergic contact dermatitis
• Otitis externa if used improperly in ear
• Damage to tooth enamel or gums with excessive dental use

• No significant systemic drug interactions due to topical application and minimal absorption.
• Avoid concurrent use with other otic or oral topical agents unless advised by healthcare professional.

• Recent guidelines emphasize proper use of cerumenolytic agents like carbamide peroxide to reduce unnecessary ear irrigation complications.
• Dental bleaching protocols recommend controlled concentrations and durations to minimize enamel damage and sensitivity.
• Regulatory updates encourage patient education on risks of over-the-counter dental bleaching products.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light and moisture.
• Keep container tightly closed.
• Keep out of reach of children.