EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid 
Humco Holding Group, 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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Private Label Earwax Removal- 0097

Citric Acid

Flavor

Glycerin

Propylene Glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified Water

Earwax removal aid.

Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

For External Use Only.

Ask a doctor before use if you have:

Ear drainage or discharge

Ear pain, irritation, or rash in the ear

Recently had ear surgery

Dizziness

An injury or perforation (hole) of the eadrum

Carbamide Peroxide 6.5%

For occasional use as an aid to soften, loosen and remove excessive earwax.

CVS Label

CVSWax.jpgcarton

Leader Label

Leader2022LDREarwax45.jpgLDREwawax90.jpg

Rite Aid Label

Rite Aid Earwax Kit 2022RAEarwax45.jpgRAEarwax90.jpg

Major Label

MajorEarwax90.jpg

EARWAX REMOVAL DROPS 
carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9133
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM STANNATE (UNII: NJ7C1V83KG)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9133-901 in 1 CARTON06/04/2019
115 mL in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:0395-9133-451 in 1 CARTON06/04/2019
215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34406/04/2019
Labeler - Humco Holding Group, Inc (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-9133) , analysis(0395-9133) , pack(0395-9133) , label(0395-9133)

Revised: 6/2022
Document Id: e21d6538-8320-1b55-e053-2a95a90a50de
Set id: a8c052d8-fb9c-09f2-e053-2a95a90a37af
Version: 4
Effective Time: 20220623
 
Humco Holding Group, Inc