solution of

solution of
SPL v12
SPL
SPL Set ID 6e5709b4-cc56-4768-b704-1d9b0e3efec7
Route
topical
Published
Effective Date 2022-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrogen peroxide (3 mL)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1993-09-01

Purpose

First aid antiseptic/Oral debriding agent

Description

Drug Facts


Medication Information

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
Purpose

First aid antiseptic/Oral debriding agent

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.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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
Section 50567-7

For external use only

Section 50569-3

Ask a doctor before use if you havedeep or puncture wounds, animal bites or serious burns

Section 50570-1

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week
Active Ingredient

Hydrogen Peroxide (stabilized) 3%

Inactive Ingredient

Purified Water

Principal Display Panel 473 Ml Bottle Label

OPTIMATES

HYDROX

CHEMICALS

TRADEMARK

SINCE 1913

Hydrox

NDC 10565-001-16

SOLUTION OF

HYDROGEN PEROXIDE

3% USP 10 VOLUME

3%

TAMPER EVIDENT CAP FOR YOUR PROTECTION.

IF RING-BAND IS DETACHED FROM CAP OR MISSING DO NOT USE.

FIRST AID ANTISEPTIC

Made in USA

16 FL. OZ. (473 mL)


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, mucous, or other secretions associated with occasional sore mouth
Purpose

First aid antiseptic/Oral debriding agent

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 (Other information)

Keep tightly closed in a cool dark place. Do not shake bottle. Hold away from face when opening.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

For external use only

Section 50569-3 (50569-3)

Ask a doctor before use if you havedeep or puncture wounds, animal bites or serious burns

Section 50570-1 (50570-1)

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week
Active Ingredient (Active ingredient)

Hydrogen Peroxide (stabilized) 3%

Inactive Ingredient (Inactive ingredient)

Purified Water

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

OPTIMATES

HYDROX

CHEMICALS

TRADEMARK

SINCE 1913

Hydrox

NDC 10565-001-16

SOLUTION OF

HYDROGEN PEROXIDE

3% USP 10 VOLUME

3%

TAMPER EVIDENT CAP FOR YOUR PROTECTION.

IF RING-BAND IS DETACHED FROM CAP OR MISSING DO NOT USE.

FIRST AID ANTISEPTIC

Made in USA

16 FL. OZ. (473 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)