EAR DROPS MAJOR- carbamide peroxide 6.5% liquid

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
09-01-2021

Aktiivinen ainesosa:

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

Saatavilla:

REMEDYREPACK INC.

Antoreitti:

AURICULAR (OTIC)

Prescription tyyppi:

OTC DRUG

Käyttöaiheet:

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

Valtuutuksen tilan:

OTC monograph final

Valmisteyhteenveto

                                EAR DROPS MAJOR- CARBAMIDE PEROXIDE 6.5% LIQUID
REMEDYREPACK 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.
DRUG: Ear DropsMajor Major
GENERIC: Carbamide Peroxide 6.5%
DOSAGE: LIQUID
ADMINSTRATION: AURICULAR (OTIC)
NDC: 70518-0524-0
NDC: 70518-0524-1
PACKAGING: 15 mL in 1 BOTTLE
OUTER PACKAGING: 1 in 1 CARTON
ACTIVE INGREDIENT(S):
CARBAMIDE PEROXIDE 6.5g in 100mL
INACTIVE INGREDIENT(S):
SOD
                                
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