LEADER EARWAX REMOVAL KIT- carbamide peroxide 6.50% kit liquid

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Cardinal Health, 110 dba Leader

给药途径:

AURICULAR (OTIC)

处方类型:

OTC DRUG

疗效迹象:

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

授权状态:

OTC monograph final

产品特点

LEADER EARWAX REMOVAL KIT- CARBAMIDE PEROXIDE 6.50% KIT LIQUID
CARDINAL HEALTH, 110 DBA LEADER
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LEADER EARWAX REMOVAL KIT
Carbamide Peroxide 6.5% non USP*
*pH differs from USP specifications
Earwax removal aid
For occasional use as an aid to soften, loosen, and remove excessive
earwax.
Ask a doctor before use if you have:
ear drainage or discharge
ear pain, irritation, or rash in ear
recently had ear surgery
dizziness
an injury or perforation of the eardrum
Citric acid
Flavor
Glyrcerin
Propylene glycol
Sodium Lauroyl Sarcosinate
Sodium Stannate
Purified water
​tilt head sideways
palce 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 four days if needed, or as directed by a
doctor
any wax remaining after treatment may be removed by gently flushing
ear with warm
water, using a soft rubber bulb ear syringe
If swallowed, get medical help or contact a Posion Control Center
right away.
LEADER EARWAX REMOVAL KIT
carbamide peroxide 6.50% kit liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70000-0490
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
6.5 g
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM STANNATE (UNII: NJ7C1V83KG)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70000-
0490-2
15 mL in 1 CONTAINER; Type 0: Not a Combination
Product
05/06/2019
2
NDC:70000-
0490-1
1 in 1 CARTON
05/06/2019
Cardinal Health, 110 dba Leader
2
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRA