Other
Drug Facts
For external use only
Anbesol Cold Sore Therapy
FDA Label NDC 0573-0246
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glaxosmithkline Consumer Healthcare Holdings (us) Llc for the product Anbesol Cold Sore Therapy (NDC 0573-0246). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, methemoglobinemia warning, allergy alert, do not use on, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purposes |
|---|---|
| Allantoin 1% | Skin protectant |
| Benzocaine 20% | Fever blister/cold sore treatment |
| Camphor 3% | Fever blister/cold sore treatment |
| White petrolatum 64.9% | Skin protectant |
Uses
- temporarily relieves pain associated with fever blisters and cold sores
- relieves dryness and softens fever blisters and cold sores
Methemoglobinemia Warning
Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Allergy Alert
Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
Do Not Use On
- deep or puncture wounds
- animal bites
- serious burns
When Using This Product
- avoid contact with the eyes
- do not exceed recommended dosage
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- to open tube, cut tip of the tube on score mark with scissors
- adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
- children under 12 years of age: adult supervision should be given in the use of this product
- children under 2 years of age: consult a doctor
Other Information
store at 20-25°C (68-77°F)
Inactive Ingredients
aloe barbadensis leaf extract, benzyl alcohol, butylparaben, glyceryl monostearate, isocetyl stearate, menthol, methylparaben, mineral oil, propylparaben, sodium lauryl sulfate, vitamin E, white wax
Questions Or Comments?
Call weekdays 9AM to 5PM EST at 1-888-797-5638
Principal Display Panel - 9 G Tube Label
ointment
Anbesol®
Cold Sore THERAPY
Fever Blister/
Cold Sore
Treatment
MAXIMUM STRENGTH
NET WT
0.33 OZ
(9 g)
Principal Display Panel - 9 G Tube Blister Pack Label
ointment
WITH
Vitamin E
& Aloe
See new warnings information
Anbesol®
Fever Blister/Cold Sore Treatment
Cold Sore THERAPY
MAXIMUM
STRENGTH
DOCTOR
RECOMMENDED
Instant
Pain Relief
✓ Cold Sores and
Fever Blisters✓ Moisturizes While It
Treats and Protects
NET WT 0.33 OZ (9 g)
Safety Sealed Tube:
Do Not Use if tube tip is cut prior to opening.
Principal Display Panel (9 g Tube Blister Pack Label)
* Please review the disclaimer below.
