HYDROGEN PEROXIDE- hydrogen peroxide liquid 
UBQ Industries, 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 3%

Hydrogen Peroxide 3%

Hydrogen Peroxide 3% v/v First aid anitseptic debriding agent

First aid antiseptic debriding agent

First aid antiseptic debriding agent

Indications and usage section

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

Warnings Section

For external use only

Do not use

• In the eyes or apply over large areas of the body
• Longer than one week

Ask a doctor before use if you have

• Deep puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

• Swelling, rash, or fever develops
• The condition persists or gets worse
• Sore mouth symptoms do not improve in 7 days
• Irritation, pain, or redness persists or worsens

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions For use as a first aid antiseptic:

• Clean affected area
• If bandaged, let fry first
• Apply small amount of product on affected area 1 – 3 times a day
• May be covered with a sterile bandage
For use as an oral debriding agent (oral rinse):
Adults and children 2 years of age
• Mix with equal amount of water
• Swish around in the mouth over affect area for at least 1 minute and then spit out. Do not swallow
• Use up to 4 times 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 doctor or dentist

Other Information

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

Inactive Ingredients

Purified water

Package Label - Principal Display Panel

236 ml NDC 80668-313-04

236 ml - hydro

473.2 ml NDC 80668-313-03 473.2 ml - hydro

18927 ml NDC 80668-313-01 18927ml - hydrogen

946.4 ml NDC 80668-313-02 946.4 ml - Hydro

HYDROGEN PEROXIDE 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80668-313
Route of AdministrationDENTAL, ORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.03 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80668-313-0118927 mL in 1 PAIL; Type 0: Not a Combination Product03/20/2020
2NDC:80668-313-02946.4 mL in 1 JUG; Type 0: Not a Combination Product03/20/2020
3NDC:80668-313-03473.2 mL in 1 JUG; Type 0: Not a Combination Product03/20/2020
4NDC:80668-313-04236 mL in 1 JUG; Type 0: Not a Combination Product03/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/20/2020
Labeler - UBQ Industries, LLC (069021187)
Registrant - UBQ Industries, LLC (069021187)
Establishment
NameAddressID/FEIBusiness Operations
UBQ Industries, LLC069021187manufacture(80668-313) , relabel(80668-313) , repack(80668-313)

Revised: 11/2021
Document Id: d1780d6d-6df8-6eb8-e053-2a95a90ab3b5
Set id: b5f97f09-8e71-b151-e053-2a95a90a865e
Version: 3
Effective Time: 20211123
 
UBQ Industries, LLC