Earwax Treatment Drops by Rugby Laboratories / Product Quest Mfg. Drug Facts

Earwax Treatment Drops by

Drug Labeling and Warnings

Earwax Treatment Drops by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EARWAX TREATMENT DROPS RUGBY- carbamide peroxide 6.5% liquid 
Rugby Laboratories

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

Active ingredient                        Purpose

Carbamide peroxide  6.5%          Earwax removal aid

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

Purpose

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

Keep out of reach of children

DirectionsFor 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

EARWAX TREATMENT DROPS  RUGBY
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1124
Route of Administration	AURICULAR (OTIC)

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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Lauroyl Sarcosinate (UNII: 632GS99618)
Sodium Stannate (UNII: NJ7C1V83KG)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1124-94	1 in 1 CARTON	02/01/2017	11/30/2019
1		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	02/01/2017	11/30/2019

Labeler - Rugby Laboratories (079246066)

Registrant - Product Quest Mfg. (927768135)

Revised: 1/2019

Document Id: 3d7929f7-c894-4301-bd5d-cc90d80e3f29

34390-5

Set id: b85dbfb0-8601-4603-af9f-397569cce612

Version: 2

Effective Time: 20190115

 

Rugby Laboratories