Country: United States
Language: English
Source: NLM (National Library of Medicine)
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
Rite Aid
AURICULAR (OTIC)
OTC DRUG
Carbamide peroxide 6.5% Earwax removal aid For occasional use as an aid to soften, loosen and remove excessive earwax
OTC monograph final
EAR WAX RMVL RITE AID- CARBAMIDE PEROXIDE 6.5% LIQUID RITE AID ---------- RITE AID EARWAX BOTTLE ACTIVE INGREDIENT PURPOSE Carbamide peroxide 6.5% Earwax removal aid USES For occasional use as an aid to soften, loosen and remove excessive earwax WARNINGS 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 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 RITE AID EARWAX KIT EAR WAX RMVL RITE AID carbamide peroxide 6.5% liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:11822-1224 ROUTE OF ADMINISTRATION AURICULAR (OTIC) ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 6.5 g in 100 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Rite Aid SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) SODIUM STANNATE (UNII: NJ7C1V83KG) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PACKAGING Read the complete document