Heb 024.000/024ab

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (15 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 2020-03-15

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

Questions?

Call 1-888-593-0593

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

*This product is not manufactured or distributed by Church & Dwight Co., Inc distributor of Orajel.

SEALED WITH PRINTED NACKBAND FOR YOUR PROTECTION

Made with pride and care for HEB San Antonio, TX 78204

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

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

Principal Display Panel

*Compare to Orajel™

HEB

Oral Sore

Antiseptic Rinse

Temporary pain relief for mouth sores
For mouth sores, including gum irritation from braces or dentures and canker sores

16 FL OZ (1 PT) 473 mL

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

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

Questions?

Call 1-888-593-0593

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)

*This product is not manufactured or distributed by Church & Dwight Co., Inc distributor of Orajel.

SEALED WITH PRINTED NACKBAND FOR YOUR PROTECTION

Made with pride and care for HEB San Antonio, TX 78204

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

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

Principal Display Panel (Principal display panel)

*Compare to Orajel™

HEB

Oral Sore

Antiseptic Rinse

Temporary pain relief for mouth sores
For mouth sores, including gum irritation from braces or dentures and canker sores

16 FL OZ (1 PT) 473 mL

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

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

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Raw Label Data

All Sections (JSON)

{"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": "Oral debriding agent/Oral antiseptic Oral pain reliever", "warnings": "for this product", "Questions?": "Call 1-888-593-0593", "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": "*This product is not manufactured or distributed by Church & Dwight Co., Inc distributor of Orajel. SEALED WITH PRINTED NACKBAND FOR YOUR PROTECTION Made with pride and care for HEB San Antonio, TX 78204 DSP-TN-15000 DSP-MO-34 SDS-TN-15012", "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", "Principal display panel": "*Compare to Orajel™ HEB Oral Sore Antiseptic Rinse Temporary pain relief for mouth sores For mouth sores, including gum irritation from braces or dentures and canker sores 16 FL OZ (1 PT) 473 mL", "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", "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"}