Active Ingredient
Hydrogen Peroxide ( Stablized) 3%
Comfort
FDA Label NDC 50827-650
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Weimei Lianyungang Household Articles Manufacturing, Co. Ltd for the product Comfort (NDC 50827-650). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, package label, purpose, uses, warnings, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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
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
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