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:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

EARWAX REMOVAL DROPS- CARBAMIDE PEROXIDE 6.5% LIQUID
HUMCO HOLDING GROUP, INC
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PRIVATE LABEL EARWAX REMOVAL- 0097
Citric Acid
Flavor
Glycerin
Propylene Glycol
Sodium Lauroyl Sarcosinate
Sodium Stannate
Purified Water
Earwax removal aid.
Adults and children over 12 yrs of age: tilt head to the side and
place 5 to 10 drops into
the ear canal.
Keep out of the reach of children. If swallowed, get medical help or
contact a Poison
Control Center right away.
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 ear surgery
Dizziness
An injury or perforation (hole) of the eadrum
Carbamide Peroxide 6.5%
For occasional use as an aid to soften, loosen and remove excessive
earwax.
CVS LABEL
LEADER LABEL
RITE AID LABEL
MAJOR LABEL
EARWAX REMOVAL DROPS
carbamide peroxide 6.5% liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0395-9133
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
WATER (UNII: 059QF0KO0R)