EAR DROPS (CARBAMIDE PEROXIDE 6.5%) MAJOR- carbamide peroxide 6.5% liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)

Available from:

NuCare Pharmaceuticals,Inc.

Administration route:

AURICULAR (OTIC)

Prescription type:

OTC DRUG

Therapeutic indications:

Earwax Removal Aid For occasional use as an aid to soften. loosen and remove excessive earwax.

Authorization status:

OTC monograph final

Summary of Product characteristics

EAR DROPS (CARBAMIDE PEROXIDE 6.5%) MAJOR- CARBAMIDE PEROXIDE
6.5% LIQUID
NUCARE PHARMACEUTICALS,INC.
_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._
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EAR DROPS MAJOR
Carbamide Peroxide 6.5%
Earwax Removal Aid
For occasional use as an aid to soften. loosen and remove excessive
earwax.
Ask doctor before use if you have • ear drainage or discharge •
ear pain • irritation or
rash in ear • dizziness • an injury or perforation (hole) of the
eardrum • recently had ear
surgery
When using this product avoid contact with eyes
Stop and ask doctor before use if • you need to use for more than
four days •
excessive earwax remains after use of this product
Stop use and ask a doctor if ​
you need to use for more than four days • excessive
earwax remains after use of this product
Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control
Center right away
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 of age: consult a doctor.
Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl
Sarcosinate, Sodium
Stannate, Water
If swallowed, get medical help or contact a Poison Control Center
right away.
EAR DROPS (CARBAMIDE PEROXIDE 6.5%) MAJOR
carbamide peroxide 6.5% liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:68071-2568(NDC:0904-6627)
ROUTE OF ADMINISTRATION
AURICULAR (OTIC)
ACTIVE INGREDIENT/ACTIVE MOIETY