Clear Canal 15 mL

Drug Labeling and Warnings

Drug Details [pdf]

CLEAR CANAL EARWAX SOFTENER DROPS- clear canal earwax softener drops solution/ drops 
NeilMed Pharmaceuticals, Inc.

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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Clear Canal 15 mL

Warnings

Warnings

Do Not Use and consult a doctor if you have excessive drainage or discharge ear pain, irritation, or rash in the ear or feel dizzy. Do not use if you have an perforation (hole) of the eardrum or after ear surger unless directed by a doctor. Do not use for more than four days. If excessive earwax remains after use of this products, consult a doctor.

Image Reference: Clear Canal Earwax Softner Drop Product Label.jpg

Clear Canal Earwax Softner Drops Outer box carton.jpg

Dosage and Administration

For use in the ear only. Adult and Children over 12 years of age: Tilt head sideways and place 5-10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in the ear for 3 to 5 minutes by keeping your head tilted or use earplugs. Rinse ear after treatment by gently flushing the ear with NeilMed ClearCanal (supplied in a canister with a special ear rinse adapter). Use twice daily for up to four days if needed or as directed by a doctor. Children under 12 years of age: Consult a doctor.

Keep this & all drugs out of the reach of children. In case of accident ingestion, seek professional assistance or contact a poison control center.

Indication and Usage

For use in the ear only. Adult and Children over 12 years of age: Tilt head sideways and place 5-10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in the ear for 3 to 5 minutes by keeping your head tilted or use earplugs. Rinse ear after treatment by gently flushing the ear with NeilMed ClearCanal (supplied in a canister with a special ear rinse adapter). Use twice daily for up to four days if needed or as directed by a doctor. Children under 12 years of age: Consult a doctor.

OTC Purpose Section

For use in the ear only. Adult and Children over 12 years of age: Tilt head sideways and place 5-10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in the ear for 3 to 5 minutes by keeping your head tilted or use earplugs. Rinse ear after treatment by gently flushing the ear with NeilMed ClearCanal (supplied in a canister with a special ear rinse adapter). Use twice daily for up to four days if needed or as directed by a doctor. Children under 12 years of age: Consult a doctor.

OTC Active Ingredient Section

Carbamide Peroxide

Inactive Ingredient Section

Glycerine

Package Label Principal Display Panel
Image reference: Clear Canal Earwax Softner Drop Product Label.jpg

Clear Canal Earwax Softner Drops Outer box carton.jpg

Package Label Principal Display Panel

Image reference: Clear Canal Earwax Softner Drop Product Label.jpg

Clear Canal Earwax Softner Drops Outer box carton.jpg Clear Canal Earwax Softner Drops Outer box CartonClear Canal Earwax Softner Drop Product Label

CLEAR CANAL EARWAX SOFTENER DROPS 
clear canal earwax softener drops solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 13710-230
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 70 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 13710-230-1515 mL in 1 BOX; Type 0: Not a Combination Product02/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/16/201902/16/2019
Labeler - NeilMed Pharmaceuticals, Inc. (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals, Inc799295915manufacture(13710-230)

Revised: 5/2019