Campho-phenique ®

SPL v4

SPL

SPL Set ID 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6

Route

TOPICAL

Published

Effective Date 2021-10-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (10.8 g) Phenol (4.7 g)

Inactive Ingredients

Silicon Dioxide Eucalyptus Oil Glycerin Light Mineral Oil Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-08-01

Description

Drug Facts

Purpose

Pain reliever/antiseptic

Medication Information

Purpose

Pain reliever/antiseptic

Description

Drug Facts

Uses

for temporary relief of pain and itching associated with cold sores and fever blisters
first aid to help prevent infection

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. Do not induce vomitingbefore contacting medical help or a Poison Control Center.

Section 50567-7

When using this productdo not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Purposes

Pain reliever/antiseptic

Warnings

For external use only

Directions

adults and children 2 years of age and over:
- clean the affected area
- apply a small amount of this product to the cold sore or fever blister 1 to 3 times daily
- do not bandage
children under 2 years of age: ask a doctor

Do Not Use

over large areas of the body
with a bandage

Active Ingredient

Camphorated phenol (camphor 10.8% and phenol 4.7%)

Other Information

store at room temperature. Avoid excessive heat above 40°C (104°F).
close cap tightly after use

Inactive Ingredients

light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf extract, glycerin, eucalyptus oil

Questions Or Comments?

1-855-602-2676weekdays 9 AM to 5 PM EST

Stop Use and Ask A Doctor If

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Ask A Doctor Before Use If You Have

a deep or puncture wound
animal bites
serious burns

Principal Display Panel 6.5 G Tube Carton

with

aloe

MAXIMUM STRENGTH

MEDICATED

CAMPHO

PHENIQUE ^®

COLD SORE

TREATMENT GEL

Fights cold sores with a powerful formula to:

immediately relieve

pain & itch

dry

cold sore

moisturize

surrounding area

Helps prevent infection

NET WT 0.23 OZ (6.5 g)

Structured Label Content

Uses

for temporary relief of pain and itching associated with cold sores and fever blisters
first aid to help prevent infection

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. Do not induce vomitingbefore contacting medical help or a Poison Control Center.

Section 50567-7 (50567-7)

When using this productdo not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Purposes

Pain reliever/antiseptic

Warnings

For external use only

Directions

adults and children 2 years of age and over:
- clean the affected area
- apply a small amount of this product to the cold sore or fever blister 1 to 3 times daily
- do not bandage
children under 2 years of age: ask a doctor

Do Not Use (Do not use)

over large areas of the body
with a bandage

Active Ingredient (Active ingredient)

Camphorated phenol (camphor 10.8% and phenol 4.7%)

Other Information (Other information)

store at room temperature. Avoid excessive heat above 40°C (104°F).
close cap tightly after use

Inactive Ingredients (Inactive ingredients)

light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf extract, glycerin, eucalyptus oil

Questions Or Comments? (Questions or comments?)

1-855-602-2676weekdays 9 AM to 5 PM EST

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a deep or puncture wound
animal bites
serious burns

Principal Display Panel 6.5 G Tube Carton (PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton)

with

aloe

MAXIMUM STRENGTH

MEDICATED

CAMPHO

PHENIQUE ^®

COLD SORE

TREATMENT GEL

Fights cold sores with a powerful formula to:

immediately relieve

pain & itch

dry

cold sore

moisturize

surrounding area

Helps prevent infection

NET WT 0.23 OZ (6.5 g)

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "10.8", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PHENOL", "unii": "339NCG44TV", "classCode": "ACTIB", "strengthNumerator": "4.7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for temporary relief of pain and itching associated with cold sores and fever blisters first aid to help prevent infection", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not induce vomiting before contacting medical help or a Poison Control Center.", "50567-7": "When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.", "Purposes": "Pain reliever/antiseptic", "Warnings": "For external use only", "Directions": "adults and children 2 years of age and over: clean the affected area apply a small amount of this product to the cold sore or fever blister 1 to 3 times daily do not bandage children under 2 years of age: ask a doctor", "Do not use": "over large areas of the body with a bandage", "Active ingredient": "Camphorated phenol (camphor 10.8% and phenol 4.7%)", "Other information": "store at room temperature. Avoid excessive heat above 40°C (104°F). close cap tightly after use", "Inactive ingredients": "light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf extract, glycerin, eucalyptus oil", "Questions or comments?": "1-855-602-2676 weekdays 9 AM to 5 PM EST", "Stop use and ask a doctor if": "condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days", "Ask a doctor before use if you have": "a deep or puncture wound animal bites serious burns", "PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton": "with aloe MAXIMUM STRENGTH MEDICATED CAMPHO PHENIQUE ® COLD SORE TREATMENT GEL Fights cold sores with a powerful formula to: immediately relieve pain & itch dry cold sore moisturize surrounding area Helps prevent infection NET WT 0.23 OZ (6.5 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:34.960482 · Updated: 2026-03-14T23:05:25.370894