COMFORT- hydrogen peroxide liquid

COMFORT by

Drug Labeling and Warnings

COMFORT by is a Otc medication manufactured, distributed, or labeled by Weimei Lianyungang Household Articles manufacturing, Co. LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrogen Peroxide ( Stablized) 3%

Package Label

Hydrogen Peroxide

Purpose

First Aid Antiseptics/Oral Debriding Agent

Uses

First aid to help prevent the risk of infection in minor cuts, scrapes and burns. Aids in the removal of phlegm, mucus, or other secrections assocated with occasional sore mouth

Warnings

For External Use only

Do not use: in the eyes or apply over large areas of the body longer than a week

Ask a doctor bbefore use if you have deep or punture wounds, animal bits or serious burns

Stop use and ask a doctor if the condition persists or gets worse. Sore mouth symptoms do not improve in 7 days.

Irriation, pain or redness persists or worsens. swelling, rash, or fever develops. Keep reach out of children. If swallowed, get medical help or contact a poison control center immediately.

KEEP OUT OF REACH OF CHILDREN

Keep reach out of children. If swallowed, get medical help or contact a poison control center immediately.

Directions

first aid antiseptic:

clean affected area
apply small amount of product on affected area 1-3 times a day
may be covered with a sterile bandage
if bandage, let dry first

oral debriding agent (oral rinse):

adults and children 2 years of age and over
mix with an equal amount of water
swish around in the mouth over affected area for atleast 1 minute and spit out
use up to 4x daily after meals and at bedtime or as directed by a dentist or doctor.

children under 12 years should be supervised in the use of this product
children under 2 years of age; consult a dentist or doctor

DOSAGE & ADMINISTRATION

first aid antiseptic:

clean affected area
apply small amount of product on affected area 1-3 times a day
may be covered with a sterile bandage
if bandage, let dry first

oral debriding agent (oral rinse):

adults and children 2 years of age and over
mix with an equal amount of water
swish around in the mouth over affected area for atleast 1 minute and spit out
use up to 4x daily after meals and at bedtime or as directed by a dentist or doctor.

children under 12 years should be supervised in the use of this product
children under 2 years of age; consult a dentist or doctor

Other Information

Keep tightly closed and in a dark place at a controlled room temperature. Do not shake bottle. Hold away from face when opening.

Inactive Ingredient

Purified water

INGREDIENTS AND APPEARANCE

COMFORT 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50827-650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50827-650-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2012

Labeler - Weimei Lianyungang Household Articles manufacturing, Co. LTD (546100731)

Registrant - Weimei Lianyungang Household Articles manufacturing, Co. LTD (546100731)

Establishment
Name	Address	ID/FEI	Business Operations
Weimei Lianyungang Household Articles manufacturing, Co. LTD		546100731	manufacture(50827-650)