Premier Value 871.001/871aa

Premier Value 871.001/871aa
SPL v17
SPL
SPL Set ID a055003d-2ea6-48f9-afa7-87d545447cd8
Route
TOPICAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (30 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2003-08-13 Until 2025-09-28

Description

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic Oral debriding agent


Medication Information

Purpose

First aid antiseptic

Oral debriding agent

Description

Hydrogen peroxide (stabilized) 3%

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 secretions associated with occasional sore mouth
Warnings

For external use only

Directions

First Aid antiseptic:

  • clean the affected area
  • apply a small amount of product on the affected 1 to 3 times a day
  • may be covered with sterile bandage
  • if bandaged, let dry first



Oral debriding agent: adults, children over 2 years of age:

  • mix with equal amount of water
  • swish around in the mouth over the affected area for at least 1 minute, then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by dentist or doctor

  • children under 12 years of age should be supervised in the use
  • children under 2 years of age: consult a dentist or doctor
Do Not Use
  • in the eyes or apply over large areas of the body
  • longer than 1 week
Adverse Reaction

DISTRIBUTED BY: Pharmacy Value Alliance LLC,

407 East Lancaster Avenue, Wayne. PA 19087 

www.emersongroup.com

Pat. D675, 101

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Other Information

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive Ingredient

purified water

Principal Display Panel

Premier Value ®

Hydrogen Peroxide

topical solution USP

first aid antiseptic

oral debriding agent

Do not use if printed seal under cap is broken or missing

INDEPENDENTLY TESTED (PV) SATISFACTION GUARANTEED

32 FL OZ (1 QT) 946 mL

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.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites or serious burns


Structured Label Content

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 secretions associated with occasional sore mouth
Purpose

First aid antiseptic

Oral debriding agent

Warnings

For external use only

Directions

First Aid antiseptic:

  • clean the affected area
  • apply a small amount of product on the affected 1 to 3 times a day
  • may be covered with sterile bandage
  • if bandaged, let dry first



Oral debriding agent: adults, children over 2 years of age:

  • mix with equal amount of water
  • swish around in the mouth over the affected area for at least 1 minute, then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by dentist or doctor

  • children under 12 years of age should be supervised in the use
  • children under 2 years of age: consult a dentist or doctor
Do Not Use (Do not use)
  • in the eyes or apply over large areas of the body
  • longer than 1 week
Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY: Pharmacy Value Alliance LLC,

407 East Lancaster Avenue, Wayne. PA 19087 

www.emersongroup.com

Pat. D675, 101

Active Ingredient (Active ingredient)

Hydrogen peroxide (stabilized) 3%

Other Information (Other information)

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive Ingredient (Inactive ingredient)

purified water

Principal Display Panel (principal display panel)

Premier Value ®

Hydrogen Peroxide

topical solution USP

first aid antiseptic

oral debriding agent

Do not use if printed seal under cap is broken or missing

INDEPENDENTLY TESTED (PV) SATISFACTION GUARANTEED

32 FL OZ (1 QT) 946 mL

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites or serious burns


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)