Label: COMFORT- hydrogen peroxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50827-650-16 - Packager: Weimei Lianyungang Household Articles manufacturing, Co. LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated May 24, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Package Label
- Purpose
- Uses
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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
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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
- Inactive Ingredient
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INGREDIENTS AND APPEARANCE
COMFORT
hydrogen peroxide liquidProduct 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)
