HYDROGEN PEROXIDE liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)
Available from:
UBQ Industries, LLC
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
• 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 • In the eyes or apply over large areas of the body • Longer than one week • Deep puncture wounds, animal bites or serious burns • 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
Authorization status:
OTC monograph not final
Authorization number:
80668-313-01

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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

18927 ml NDC 80668-313-01

HYDROGEN PEROXIDE

hydrogen peroxide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 6 6 8 -313

Route of Administration

DENTAL, ORAL, TOPICAL

UBQ Industries, LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V) (HYDROGEN PEROXIDE -

UNII:BBX0 6 0 AN9 V)

HYDROGEN

PEROXIDE

0 .0 3 mL

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 0 6 6 8 -313-0 1

18 9 27 mL in 1 PAIL; Type 0 : No t a Co mbinatio n Pro duct

0 3/20 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 3/20 /20 20

Labeler -

UBQ Industries, LLC (069021187)

Registrant -

UBQ Industries, LLC (069021187)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

UBQ Industries, LLC

0 6 9 0 2118 7

manufacture(8 0 6 6 8 -313) , relabel(8 0 6 6 8 -313) , repack(8 0 6 6 8 -313)

Revised: 12/2020

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