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NDC 00363-2068-25 Walgreens Ear Wax Remover 0.065 mg/mL Details

Walgreens Ear Wax Remover 0.065 mg/mL

Walgreens Ear Wax Remover is a AURICULAR (OTIC) LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens Company. The primary component is CARBAMIDE PEROXIDE.

Product Information

NDC	00363-2068
Product ID	0363-2068_f2819e70-f156-427f-bfd3-fa7029637c6e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Walgreens Ear Wax Remover
Proprietary Name Suffix	n/a
Non-Proprietary Name	Carbamide Peroxide 6.5%
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	AURICULAR (OTIC)
Active Ingredient Strength	0.065
Active Ingredient Units	mg/mL
Substance Name	CARBAMIDE PEROXIDE
Labeler Name	Walgreens Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part344
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-2068-25 (00363206825)

Pricing Information	N/A
NDC Package Code	0363-2068-25
Billing NDC	00363206825
Package	1 BOTTLE, DROPPER in 1 KIT (0363-2068-25) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2014-04-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d3b7362b-2826-4b86-bfa3-ef302dc79143 Details

Active ingredient

Carbamide Peroxide 6.5%

Purpose

Ear Wax Removal Aid

Uses

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

Warnings

Ask a Doctor before use if you have

eardrainage, discharge, ear pain,irritation
rash in the ear,or are dizzy
injury or perforation (hole) of the ear drum
Recently had ear surgery

Stop Use and ask a Doctor if

you need to use for more than 4 days
execessive ear wax remain after use of this product

When using this product

do not use for more than four days

avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor

if excessive earwax remains after the use of this product, consult a doctor

Keep out of the reach of children

If 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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.

Children under 12 years: consult a doctor.

Inactive Ingredients

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Other information

Protect from heat and direct sunlight

product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking

Keep cap on bottle when not in use.

Lot No. and EXP date: see label, bottom container or box.

Principal Display Panel Bottle Label 0.5 FL OZ

Walgreens Ear Wax Remover NDC 0363-2068-15

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel Carton Label 0.5 FL OZ

Walgreens Ear Wax Remover NDC 0363-2068-15

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel Kit Label 0.5 FL OZ

Walgreens Ear Wax Remover Kit NDC 0363-2068-25

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

INGREDIENTS AND APPEARANCE

WALGREENS EAR WAX REMOVER

carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-2068
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	0.065 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TARTARIC ACID (UNII: W4888I119H)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-2068-15	1 in 1 CARTON	04/28/2014
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:0363-2068-25	1 in 1 KIT	04/28/2014
2		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	04/28/2014

Labeler - Walgreens Company (008965063)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals LLC		151177797	manufacture(0363-2068)

Revised: 1/2022

Document Id: f2819e70-f156-427f-bfd3-fa7029637c6e

Set id: d3b7362b-2826-4b86-bfa3-ef302dc79143

Version: 2

Effective Time: 20220104

Search by Drug Name or NDC

NDC 00363-2068-25 Walgreens Ear Wax Remover 0.065 mg/mL Details

Walgreens Ear Wax Remover 0.065 mg/mL

Product Information

Package

Package Images

NDC 00363-2068-25 (00363206825)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d3b7362b-2826-4b86-bfa3-ef302dc79143 Details

Active ingredient

Purpose

Uses

Warnings

Stop Use and ask a Doctor if

When using this product

Keep out of the reach of children

Directions FOR USE IN THE EAR ONLY

Inactive Ingredients

Other information

Principal Display Panel Bottle Label 0.5 FL OZ

Principal Display Panel Carton Label 0.5 FL OZ

Principal Display Panel Kit Label 0.5 FL OZ

INGREDIENTS AND APPEARANCE

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