Label: CVS EARWAX REM CVS- carbamide peroxide 6.50% kit
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-042-07, 69842-043-01 - 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- Keep this and all drugs out of the reach of children.
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Directions
FOR USE IN THE EAR ONLY
adults and children over 12 years of age:
- tilt head sideways
- palce 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 ear with warm water, using a soft rubber bulb ear syringe
children under 12 years: consult a doctor
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS EARWAX REM CVS
carbamide peroxide 6.50% kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-042 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-042-07 1 in 1 KIT 11/12/2014 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 15 mL Part 1 of 1 EARWAX REMOVAL
carbamide peroxide 6.50% solution/ dropsProduct Information Item Code (Source) NDC:69842-043 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:69842-043-01 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 11/12/2014 Labeler - CVS (062312574) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(69842-042, 69842-043) , label(69842-042, 69842-043)
