Care One 024.000/024aa-ab

Care One 024.000/024aa-ab
SPL v6
SPL
SPL Set ID d46546d0-c6df-431a-8ab0-bc5013c084d7
Route
ORAL
Published
Effective Date 2025-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2023-01-13

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

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

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns,

contact us at 1-833-992-3872

Quality guaranteed or your money back.

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

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

Principal Display Panel

CAREONE

Compare to Orajel Antispetic Rinse Mouth Sores*

ORAL SORE

ANTISEPTIC RINSE

ORAL PAIN RELIEVER

ORAL DEBRIDING AGENT

FOR MOUTH SORES, INCLUDING GUM IRRITATION FROM BRACES OR DENTURES AND CANKER SORES

MINT FLAVOR

Sealed With Printed Neckband For Your Protection

NET 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

▪ 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

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)

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns,

contact us at 1-833-992-3872

Quality guaranteed or your money back.

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

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

Principal Display Panel (Principal display panel)

CAREONE

Compare to Orajel Antispetic Rinse Mouth Sores*

ORAL SORE

ANTISEPTIC RINSE

ORAL PAIN RELIEVER

ORAL DEBRIDING AGENT

FOR MOUTH SORES, INCLUDING GUM IRRITATION FROM BRACES OR DENTURES AND CANKER SORES

MINT FLAVOR

Sealed With Printed Neckband For Your Protection

NET 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


Raw Label Data

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