HCS HYDROGEN PEROXIDE 3%- hydrogen peroxide liquid 
Concordance Healthcare Solutions, LLC.

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.

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Hydrogen Peroxide
Drug Facts

Active ingredient

Hydrogen Peroxide (stabilized) 3%

Purpose

First aid antiseptic/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, mucous, or other secretions associated 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 1 week

Ask a doctor before use if you have deep or puncture wounds, animal bites 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 irritation, pain, or redness persists or worsens swelling, rash, or fever develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

First aid antiseptic:

-
clean the affected area
-
apply a small amount of product on the area 1 to 3 times daily.
-
May be covered with a sterile bandage; if bandaged, 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 the affected area for at least 1 minute and then spit out

use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

children under 12 years of age 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 in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

purified water

Principal Display Panel – 473 mL Bottle Label

HCS

NDC 83506-001-16

Solution of
Hydrogen Peroxide
3% USP 10 Volume

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

SEALED FOR YOUR PROTECTION

IF THE SEAL IS BROKEN OR MISSING DO NOT USE

16 FL OZ (1 PT) 473 mL

Principal Display Panel – 473 mL Bottle Label
HCS HYDROGEN PEROXIDE 3% 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83506-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83506-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/14/2023
2NDC:83506-001-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/14/2023
3NDC:83506-001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/14/2023
Labeler - Concordance Healthcare Solutions, LLC. (080220245)
Establishment
NameAddressID/FEIBusiness Operations
Ken Prima Cosmeceuticals SDN BHD865792209MANUFACTURE(83506-001)

Revised: 8/2023
Document Id: 7d1685e8-48f4-40a1-87f0-c44f4c369f0f
Set id: f854ff4f-1327-4e2a-9389-591b01ba3ee2
Version: 1
Effective Time: 20230814
 
Concordance Healthcare Solutions, LLC.