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NDC 49035-0862-02 Ear Wax Removal Drops 65 mg/mL Details

Ear Wax Removal Drops 65 mg/mL

Ear Wax Removal Drops is a TOPICAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by WALMART STORES INC. The primary component is CARBAMIDE PEROXIDE.

Product Information

NDC	49035-0862
Product ID	49035-862_28736548-09b6-4dcb-acdf-00ae56a6b3f4
Associated GPIs	87400030002010
GCN Sequence Number	008120
GCN Sequence Number Description	carbamide peroxide DROPS 6.5 % OTIC (EAR)
HIC3	Q8R
HIC3 Description	EAR PREPARATIONS,EAR WAX REMOVERS
GCN	34401
HICL Sequence Number	004272
HICL Sequence Number Description	CARBAMIDE PEROXIDE
Brand/Generic	Generic
Proprietary Name	Ear Wax Removal Drops
Proprietary Name Suffix	Equate
Non-Proprietary Name	Carbamide Peroxide - 6.5%
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	TOPICAL
Active Ingredient Strength	65
Active Ingredient Units	mg/mL
Substance Name	CARBAMIDE PEROXIDE
Labeler Name	WALMART STORES INC
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 49035-0862-02 (49035086202)

Pricing Information	N/A
NDC Package Code	49035-862-02
Billing NDC	49035086202
Package	1 BOTTLE, DROPPER in 1 CARTON (49035-862-02) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2019-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d Details

Active ingredient

Carbamide Peroxide, 6.5%

Purpose

Earwax 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.

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.

Inactive ingredients

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

Principal Display Panel Bottle Label 0.5 FL OZ

Equate NDC 49035-862-02

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel - Carton label 0.5 FL OZ

Equate NDC 49035-862-02

Ear wax Remover Drops

Carbamide Peroxide 6.5%

Ear wax removal aid

0.5 FL OZ ( 15ml)

Principal Display Panel - Carton label KIT 0.5 FL OZ

Equate NDC 49035-862-02

Ear wax Remover Kit

Carbamide Peroxide 6.5%

Ear wax removal aid

0.5 FL OZ ( 15ml)

INGREDIENTS AND APPEARANCE

EAR WAX REMOVAL DROPS EQUATE

carbamide peroxide - 6.5% solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-862
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	65 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:49035-862-02	1 in 1 CARTON	03/01/2019
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:49035-862-01	1 in 1 KIT	03/01/2019
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	03/01/2019

Labeler - WALMART STORES INC (051957769)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals LLC		151177797	manufacture(49035-862)

Revised: 11/2018

Document Id: 28736548-09b6-4dcb-acdf-00ae56a6b3f4

Set id: 33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d

Version: 1

Effective Time: 20181107

Search by Drug Name or NDC

NDC 49035-0862-02 Ear Wax Removal Drops 65 mg/mL Details

Ear Wax Removal Drops 65 mg/mL

Product Information

Package

Package Images

NDC 49035-0862-02 (49035086202)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d 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

Other information

Inactive ingredients

Principal Display Panel Bottle Label 0.5 FL OZ

Principal Display Panel - Carton label 0.5 FL OZ

Principal Display Panel - Carton label KIT 0.5 FL OZ

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

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Search by Drug Name or NDC

NDC 49035-0862-02 Ear Wax Removal Drops 65 mg/mL Details

Ear Wax Removal Drops 65 mg/mL

Product Information

Package

Package Images

NDC 49035-0862-02 (49035086202)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d 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

﻿Other information

﻿Inactive ingredients

Principal Display Panel Bottle Label 0.5 FL OZ

Principal Display Panel - Carton label 0.5 FL OZ

Principal Display Panel - Carton label KIT 0.5 FL OZ

INGREDIENTS AND APPEARANCE

Purpose

Warnings

Keep out of the reach of children

Directions FOR USE IN THE EAR ONLY

Other information

Inactive ingredients