curoxen oral care

SPL v7

SPL

SPL Set ID 60cc114f-f63b-60f6-e053-2a91aa0acd53

Route

topical

Published

Effective Date 2017-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

clove oil (1 [hp_X]) olea europaea fruit volatile oil (2 [hp_X]) calendula officinalis flowering top (3 [hp_X])

Inactive Ingredients

cinnamon oil olive oil

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2017-12-20

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredients

Calendula 3X HPUS

Clove essential oil 1X

Olive extract 2X HPUS

Indications and Usage

Uses

for the temporary relief of pain and to help prevent infection and promote healing of:

canker sores
cold sores
fever blisters
minor irritation, injury, cuts or other sores of the mouth and gums.

Dosage and Administration

Directions

Adults and children of any age, apply to the affected area as needed
Children under 12 years of age should be supervised in the use of this product

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

store at 68° to 77°F (20° to 25°C)
if liquefied, refrigerate 10 minutes to thicken

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days
swelling, rash, fever or other allergic reaction develops
irritation, pain or redness persists or worsens

Section 51727-6

Inactive ingredients

oxygenated olive oil, pure essential oil (cinnamon)

Section 51945-4

MADE WITH ORGANIC INGREDIENTS

NO Artificial Drugs or Chemicals

#1 Oral Germ Killer

Instant Pain Relief

CUROXEN® ORAL CARE

A Homeopathic Medicine that provides pain relief, speeds healing, and helps prevent Infection in mouth sores

Pain relief and treatment of:

Canker sores
Cheek bites
Cold sores, and abrasions from braces & dentures

Mouth Sore Treatment

Pain Relief
Healing
Fights Infection

NET WT 0.42 oz (11.9 g)

Section 53413-1

Questions?

Call 512-401-3572 or visit www.curoxen.com

Section 55105-1

Purposes

Healing agent

Oral pain reliever

Oral antimicrobial and healing agent

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredients

Calendula 3X HPUS

Clove essential oil 1X

Olive extract 2X HPUS

Indications and Usage (34067-9)

Uses

for the temporary relief of pain and to help prevent infection and promote healing of:

canker sores
cold sores
fever blisters
minor irritation, injury, cuts or other sores of the mouth and gums.

Dosage and Administration (34068-7)

Directions

Adults and children of any age, apply to the affected area as needed
Children under 12 years of age should be supervised in the use of this product

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

store at 68° to 77°F (20° to 25°C)
if liquefied, refrigerate 10 minutes to thicken

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days
swelling, rash, fever or other allergic reaction develops
irritation, pain or redness persists or worsens

Section 51727-6 (51727-6)

Inactive ingredients

oxygenated olive oil, pure essential oil (cinnamon)

Section 51945-4 (51945-4)

MADE WITH ORGANIC INGREDIENTS

NO Artificial Drugs or Chemicals

#1 Oral Germ Killer

Instant Pain Relief

CUROXEN® ORAL CARE

A Homeopathic Medicine that provides pain relief, speeds healing, and helps prevent Infection in mouth sores

Pain relief and treatment of:

Canker sores
Cheek bites
Cold sores, and abrasions from braces & dentures

Mouth Sore Treatment

Pain Relief
Healing
Fights Infection

NET WT 0.42 oz (11.9 g)

Section 53413-1 (53413-1)

Questions?

Call 512-401-3572 or visit www.curoxen.com

Section 55105-1 (55105-1)

Purposes

Healing agent

Oral pain reliever

Oral antimicrobial and healing agent

Advanced Ingredient Data

[{"name": "CINNAMON OIL", "unii": "E5GY4I6YCZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOVE OIL", "unii": "578389D6D0", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "12", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "OLEA EUROPAEA FRUIT VOLATILE OIL", "unii": "8E7358CX1J", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "12", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "CALENDULA OFFICINALIS FLOWERING TOP", "unii": "18E7415PXQ", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "12", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses for the temporary relief of pain and to help prevent infection and promote healing of: canker sores cold sores fever blisters minor irritation, injury, cuts or other sores of the mouth and gums.", "34068-7": "Directions Adults and children of any age, apply to the affected area as needed Children under 12 years of age should be supervised in the use of this product", "34071-1": "Warnings", "42229-5": "Drug Facts", "44425-7": "Other information store at 68° to 77°F (20° to 25°C) if liquefied, refrigerate 10 minutes to thicken", "50565-1": "Keep out of reach of children. If excessive product is swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days swelling, rash, fever or other allergic reaction develops irritation, pain or redness persists or worsens", "51727-6": "Inactive ingredients oxygenated olive oil, pure essential oil (cinnamon)", "51945-4": "MADE WITH ORGANIC INGREDIENTS NO Artificial Drugs or Chemicals #1 Oral Germ Killer Instant Pain Relief CUROXEN® ORAL CARE A Homeopathic Medicine that provides pain relief, speeds healing, and helps prevent Infection in mouth sores Pain relief and treatment of: Canker sores Cheek bites Cold sores, and abrasions from braces & dentures Mouth Sore Treatment Pain Relief Healing Fights Infection NET WT 0.42 oz (11.9 g)", "53413-1": "Questions? Call 512-401-3572 or visit www.curoxen.com", "55105-1": "Purposes Healing agent Oral pain reliever Oral antimicrobial and healing agent", "55106-9": "Active ingredients Calendula 3X HPUS Clove essential oil 1X Olive extract 2X HPUS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:40.695441 · Updated: 2026-03-14T23:17:39.188617