- 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)