Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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EARWAX REMOVAL KIT RITE AID- carbamide peroxide 6.5% 
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.

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Drug Facts

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

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EARWAX REMOVAL KIT  RITE AID
carbamide peroxide 6.5% kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11822-1222
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11822-1222-71 in 1 KIT; Type 0: Not a Combination Product10/04/2011
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 mL
Part 1 of 1
EAR WAX RMVL  RITE AID
carbamide peroxide 6.5% liquid
Product Information
Item Code (Source)NDC: 11822-1224
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide Peroxide (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) Carbamide Peroxide6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Lauroyl Sarcosinate (UNII: 632GS99618)  
Sodium Stannate (UNII: NJ7C1V83KG)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11822-1224-115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/04/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/04/2011
Labeler - Rite Aid (014578892)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(11822-1224) , label(11822-1224, 11822-1222)

Revised: 6/2018
 
Rite Aid


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