Rite Aid 024.000/024ab

Rite Aid 024.000/024ab
SPL v7
SPL
SPL Set ID e67046ce-bfe0-4454-bbe8-6a3783afb6f5
Route
ORAL
Published
Effective Date 2025-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (1.5 mg) Menthol (1 mg)
Inactive Ingredients
Alcohol Fd&c Blue No. 1 Edetate Disodium Anhydrous Methyl Salicylate Phosphoric Acid Poloxamer 338 Polysorbate 20 Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-02

Description

Hydrogen peroxide 1.5% (w/v) Menthol 0.1% (w/v)

Purpose

Oral debriding agent/Oral antiseptic Oral pain reliever


Medication Information

Purpose

Oral debriding agent/Oral antiseptic

Oral pain reliever

Description

Hydrogen peroxide 1.5% (w/v) Menthol 0.1% (w/v)

Uses
  • first aid to help protect against bacterial contamination in minor oral wounds
  • for temporary pain relief and 
  • temporary use in cleansing minor wounds or minor gum inflammation resulting from: 
  • minor dental procedures 
  • dentures 
  • orthodontic appliances 
  • accidental injury 
  • other irritations of the mouth and gums 
  • canker sores
  • aids in the removal of: 
  • phlegm 
  • mucus 
  • other secretions associated with occasional sore mouth
Warnings

for this product

Disclaimer

*This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse for all Mouth Sores.

Directions

Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician

Children under 12 years of age - should be supervised in the use of the product

Children under 2 years of age - consult a dentist or doctor

Adverse Reaction

SATISFACTION GUARANTEE

If you're not satisfed, we'll happily refund your money.

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

DSP-TN-21091 DSP-MO-20087

Other Information
  • store at controlled room temperature 68-77°F (20-25°C) 
  • keep away from heat or direct sunlight
Active Ingredients

Hydrogen peroxide 1.5% (w/v)

Menthol 0.1% (w/v)

Inactive Ingredients

alcohol (4.1% v/v), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

When Using This Product
  •  do not swallow 
  •  do not use more than 7 days unless directed by a dentist or doctor 
  •  do not exceed recommended dosage
Principal Display Panel

Sealed with printed neckband for your protection

Compare to Orajel™ Antiseptic Rinse for all Mouth Sores*

ORAL SORE

ANTISEPTIC RINSE

TEMPORARY PAIN RELIEF FOR MOUTH SORES

MINT

for mouth sores, including gum irritation from braces or dentures and canker sores

kills germs and bacteria

helps alleviate pain

473 mL (16 FL OZ)

Stop Use and Ask A Doctor If
  • sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops
  • sore mouth symptoms do not improve in 7 days
Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses (uses)
  • first aid to help protect against bacterial contamination in minor oral wounds
  • for temporary pain relief and 
  • temporary use in cleansing minor wounds or minor gum inflammation resulting from: 
  • minor dental procedures 
  • dentures 
  • orthodontic appliances 
  • accidental injury 
  • other irritations of the mouth and gums 
  • canker sores
  • aids in the removal of: 
  • phlegm 
  • mucus 
  • other secretions associated with occasional sore mouth
Purpose (purpose)

Oral debriding agent/Oral antiseptic

Oral pain reliever

Warnings (warnings)

for this product

Disclaimer

*This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse for all Mouth Sores.

Directions (directions)

Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician

Children under 12 years of age - should be supervised in the use of the product

Children under 2 years of age - consult a dentist or doctor

Adverse Reaction (ADVERSE REACTION)

SATISFACTION GUARANTEE

If you're not satisfed, we'll happily refund your money.

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

DSP-TN-21091 DSP-MO-20087

Other Information (other information)
  • store at controlled room temperature 68-77°F (20-25°C) 
  • keep away from heat or direct sunlight
Active Ingredients (active ingredients)

Hydrogen peroxide 1.5% (w/v)

Menthol 0.1% (w/v)

Inactive Ingredients (inactive ingredients)

alcohol (4.1% v/v), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

When Using This Product (When using this product)
  •  do not swallow 
  •  do not use more than 7 days unless directed by a dentist or doctor 
  •  do not exceed recommended dosage
Principal Display Panel (principal display panel)

Sealed with printed neckband for your protection

Compare to Orajel™ Antiseptic Rinse for all Mouth Sores*

ORAL SORE

ANTISEPTIC RINSE

TEMPORARY PAIN RELIEF FOR MOUTH SORES

MINT

for mouth sores, including gum irritation from braces or dentures and canker sores

kills germs and bacteria

helps alleviate pain

473 mL (16 FL OZ)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops
  • sore mouth symptoms do not improve in 7 days
Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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