Label: EARWAX REM CVS- carbamide peroxide 6.50% kit
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-040-01, 69842-041-07 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated November 20, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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WARNINGS
Warnings
Ask a doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in the ear • dizziness• an injury or perforation (hole) of the eardrum • recently had ear surgery
When using this product avoid contact with the eyesStop use and ask a doctor if • you need to use for more than four days • excessive ear wax remains after use of this product
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
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DOSAGE & ADMINISTRATION
Directions
FOR USE IN THE EAR ONLY
adults and children over 12 years of age:
• tilt head sideways • 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 four 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: consult a doctor - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EARWAX REM CVS
carbamide peroxide 6.50% kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-041 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-041-07 1 in 1 KIT 05/14/2010 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 15 mL Part 1 of 1 EARWAX REM CVS
carbamide peroxide solution/ dropsProduct Information Item Code (Source) NDC:69842-040 Route of Administration TOPICAL 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMOMILE (UNII: FGL3685T2X) Glycerin (UNII: PDC6A3C0OX) Oxyquinoline Sulfate (UNII: 61VUG75Y3P) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-040-01 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 05/14/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 05/14/2010 Labeler - CVS (062312574) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(69842-040) , label(69842-040) , pack(69842-041)
