EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)

Available from:

Humco Holding Group, Inc

Administration route:

AURICULAR (OTIC)

Prescription type:

OTC DRUG

Therapeutic indications:

For occasional use as an aid to soften, loosen and remove excessive earwax. Earwax Removal Aid

Authorization status:

OTC monograph final

Summary of Product characteristics

EARWAX REMOVAL DROPS- CARBAMIDE PEROXIDE 6.5% LIQUID
HUMCO HOLDING GROUP, INC
----------
PRIVATE LABEL EARWAX REMOVAL- 0096
ADULTS & CHILDREN OVER 12 YRS OF AGE:
tilt head to the side and place 10 drops into the ear canal.
Tip of applicator should not enter into the ear canal
Keep drops in ear for several minutes by keeping head tilted sideways
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 YRS OF AGE:
Consult a physician.
For occasional use as an aid to soften, loosen and remove excessive
earwax.
Earwax Removal Aid
WARNINGS
_FOR EXTERNAL USE ONLY_
ASK A DOCTOR BEFORE USE IF YOU HAVE:
ear drainage or discharge
ear pain, irritation, or rash in the ear
recently had surgery
dizziness
an injury or perforation (hole) of the eardrum
Carbamide Peroxide 6.5%
Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Purified Water
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. If swallowed,
get medical
help or contact a Poison Control Center right away.
EARWAX REMOVAL DROPS
carbamide peroxide 6.5% liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0395-9132
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
0.065 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
Humco Holding Group, Inc
CHAMOMILE (UNII: FGL3685T2X)
OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0395-
9132-45
1 in 1 CARTON
06/05/2019
05/31/2024
1
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a
Combination Pro