Earwax treatment dropsrugby liquid

Active ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Indications & usage section

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

Warnings


Ask doctor before use if you haveear drainage or discharge ear pain irritation or rash in ear dizziness an injury or perforation (hole) of the eardrum recently had ear surgery

Otc - when using section

When using this productavoid contact with eyes

Otc - stop use section

Stop and ask doctor before use ifyou need to use for more than four days excessive earwax remains after use of this product

Otc - keep out of reach of children section

Keep out of reach of children

Dosage & administration section

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.

Inactive ingredient section

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

Ingredients and appearance - Product information

Earwax treatment dropsrugby liquid- Carbamide peroxide 6.5%

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68788-7256
Route of Administration Auricular (otic)

Active Ingredient/Active Moiety

Ingredient Name Strength
Carbamide peroxide ( UNII: 31PZ2VAU81)( Hydrogen peroxide - UNII: BBX060AN9V ) 6.5 gin 100 mL

Inactive Ingredients

Ingredient Name Code
Citric acid monohydrate ( UNII: 2968PHW8QP)
Glycerin ( UNII: PDC6A3C0OX)
Propylene glycol ( UNII: 6DC9Q167V3)
Sodium lauroyl sarcosinate ( UNII: 632GS99618)
Sodium stannate ( UNII: NJ7C1V83KG)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part344 USA

Labeler - Preferred Pharmaceuticals Inc.( 791119022)

Establishment

Name ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL( 68788-7256)

Package label.principal display panel