OTC Medication Information: EAR WAX RMVL CVS

EAR WAX RMVL CVS- carbamide peroxide liquid
CVS

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.

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 and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product

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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EAR WAX RMVL CVS
carbamide peroxide 6.5% liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-039
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbamide Peroxide (HYDROGEN PEROXIDE) Carbamide Peroxide 6.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
Glycerin
Propylene Glycol
Sodium Lauroyl Sarcosinate
Sodium Stannate
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-039-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (69842-039-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 12/24/2014
Labeler — CVS (062312574)
Registrant — Product Quest Mfg. (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg. 927768135 manufacture (69842-039), label (69842-039)

Revised: 11/2017 CVS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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