EAR DROPS MAJOR- carbamide peroxide 6.5% liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
Available from:
REMEDYREPACK INC.
Administration route:
AURICULAR (OTIC)
Prescription type:
OTC DRUG
Therapeutic indications:
Carbamide peroxide  6.5%          Earwax removal aid For occasional use as an aid to soften, loosen and remove excessive earwax
Authorization status:
OTC monograph final
Authorization number:
70518-0524-0

EAR DROPS MAJOR- carbamide peroxide 6.5% liquid

REMEDYREPACK INC.

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

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

DRUG: Ear DropsMajor Major

GENERIC: Carbamide Peroxide 6.5%

DOSAGE: LIQUID

ADMINSTRATION: AURICULAR (OTIC)

NDC: 70518-0524-0

PACKAGING: 15 mL in 1 BOTTLE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

Carbamide Peroxide 6.5g in 100mL

INACTIVE INGREDIENT(S):

CITRIC ACID MONOHYDRATE

Sodium Lauroyl Sarcosinate

Sodium Stannate

Glycerin

Propylene Glycol

Water

EAR DROPS MAJOR

carbamide peroxide 6.5% liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 518 -0 524(NDC:0 9 0 4-6 6 27)

Route of Administration

AURICULAR (OTIC)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CARBAMIDE PERO XIDE (UNII: 31PZ2VAU8 1) (HYDROGEN PEROXIDE -

UNII:BBX0 6 0 AN9 V)

CARBAMIDE

PEROXIDE

6 .5 g

in 10 0 mL

Inactive Ingredients

REMEDYREPACK INC.

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM LAURO YL SARCO SINATE (UNII: 6 32GS9 9 6 18 )

SO DIUM STANNATE (UNII: NJ7C1V8 3KG)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 518 -0 524-0

1 in 1 CARTON

0 5/11/20 17

1

15 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt344

0 5/11/20 17

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 4/2019

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