EARWAX REMOVAL DROPS  EQUATE- carbamide peroxide 6.5% liquid 
Walmart

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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Drug Facts 25-119PQ

Active ingredient                        Purpose

Carbamide peroxide  6.5%          Earwax removal aid

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

Warnings

Do not use • if you have ear drainage or discharge,
ear pain, irritation or rash in the ear or are dizzy;
consult a doctor • if you have an injury or perforation
(hole) of the ear drum or after ear surgery, unless
directed by a doctor • for more than 4 consecutive
days; if excessive earwax remains after use of this
product, consult a doctor

When using this product • avoid contact with eyes.
If accidental contact with eyes occurs, flush eyes
with water and consult a doctor

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 the 4-day 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

image descriptionimage description

EARWAX REMOVAL DROPS   EQUATE
carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-537
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
SODIUM STANNATE (UNII: NJ7C1V83KG)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-537-011 in 1 CARTON06/05/2017
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34406/05/2017
Labeler - Walmart (051957769)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(49035-537) , label(49035-537)

Revised: 12/2017
Document Id: 618083ab-73e1-1a00-e053-2a91aa0a1ccd
Set id: 4b601252-9b3b-4022-83b4-ca437254e4d9
Version: 3
Effective Time: 20171229
 
Walmart