Country: United States
Language: English
Source: NLM (National Library of Medicine)
Carbamide Peroxide (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
Rite Aid
OTC DRUG
Carbamide Peroxide - 6.50% Earwax removal aid for occasional use as an aid to soften, loosen and remove excessive ear wax If product is swallowed, get medical help or contact a Poison Control Center right away - 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. • Protect from heat and direct sunlight • Keep cup on bottle when not in use Aloe Barbadensis Leaf Extract Chamomilla Recutita (Matricaria) Flower Extract Glycerin Mineral Oil Oxyquinoline Sulfate Water
OTC monograph final
EAR WAX REMOVAL SYSTEM RITE AID- CARBAMIDE PEROXIDE - 6.50% RITE AID _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._ ---------- DRUG FACTS KIT ACTIVE INGREDIENT PURPOSE Carbamide Peroxide - 6.50% Earwax removal aid US ES for occasional use as an aid to soften, loosen and remove excessive ear wax WARNINGS FOR EXTERNAL USE ONLY 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. OTHER INFORMATION • Protect from heat and direct sunlight • Keep cup on bottle when not in use INACTIVE INGREDIENT Aloe Barbadensis Leaf Extract Chamomilla Recutita (Matricaria) Flower Extract Glycerin Mineral Oil Oxyquinoline Sulfate Water EAR WAX REMOVAL SYSTEM RITE AID carbamide peroxide - 6.50% kit PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:118 22-1225 PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:118 22-1225-7 1 in 1 KIT 10 /0 7/20 11 QUANTITY OF PARTS PART # PACKAGE QUANTITY TOTAL PRODUCT QUANTITY PA RT 1 1 BOTTLE 15 mL PART 1 OF 1 EAR WAX REMOVAL DROPS RITE AID carbamide peroxide - 6.50% solution/ drops PRODUCT INFORMATION ITE M CODE (SOURCE ) NDC:118 22-1226 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CA RBA MIDE PERO XIDE (UNII: 31PZ2VAU8 1) (HYDROGEN PEROXIDE Read the complete document