EAR WAX REMOVAL SYSTEM- carbamide peroxide - 6.50% kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Walmart

Prescription type:

OTC DRUG

Therapeutic indications:

Carbamide Peroxide - 6.50%             Earwax removal aid ​Uses ​ for occasional use as an aid to soften, loosen and remove excessive ear wax If product is swallowed, get medical help or contact a Poison Control Center right away - 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. • Protect from heat and direct sunlight • Keep cup on bottle when not in use Aloe Barbadensis Leaf Extract Chamomilla Recutita (Matricaria) Flower Extract Glycerin Mineral Oil Oxyquinoline Sulfate Water Questions or comments? 1-866-483-2846

Authorization status:

OTC monograph final

Summary of Product characteristics

EAR WAX REMOVAL SYSTEM- CARBAMIDE PEROXIDE - 6.50%
WALMART
_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._
----------
DRUG FACTS KIT 13-243PQ
STEP 1 EAR WAX REMOVAL DROPS
ACTIVE INGREDIENT PURPOSE
Carbamide Peroxide - 6.50% Earwax removal aid
USES for occasional use as an aid to soften, loosen and remove
excessive ear wax
WARNINGS
FOR EXTERNAL USE ONLY
KEEP OUT OF REACH OF THE CHILDREN
If product is 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 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.
OTHER INFORMATION
• Protect from heat and direct sunlight • Keep cup on bottle when
not in use
INACTIVE INGREDIENT
Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Water
QUESTIONS OR COMMENTS?
1-866-483-2846
EAR WAX REMOVAL SYSTEM
carbamide peroxide - 6.50% kit
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 0 35-554
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:49 0 35-554-0 7
1 in 1 KIT
0 8 /15/20 14
QUANTITY OF PARTS
PART #
PACKAGE QUANTITY
TOTAL PRODUCT QUANTITY
PA RT 1
1 BOTTLE
15 mL
PART 1 OF 1
EAR WAX REMOVAL DROPS WELL AT WALGREENS
carbamide peroxide - 6.50% solution/ drops
PRODUCT INFORMATION
ITE M CODE (SOURCE )
NDC:49 0 35-552
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE