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ANBESOL COLD SORE THERAPY

Dosage form: ointment
Ingredients: ALLANTOIN 10mg in 1g, BENZOCAINE 200mg in 1g, CAMPHOR (SYNTHETIC) 30mg in 1g, PETROLATUM 649mg in 1g
Labeler: Wyeth Consumer Healthcare LLC
NDC Code: 0573-0246

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Anbesol® Cold Sore Therapy

Drug Facts

Active ingredientsPurposes
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

Warnings

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

For external use only

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

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.

ANBESOL COLD SORE THERAPY 
allantion, benzocaine, camphor, petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0246
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN10 mg  in 1 g
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)30 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM649 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL 
BENZYL ALCOHOL 
BUTYLPARABEN 
GLYCERYL MONOSTEARATE 
ISOCETYL STEARATE 
MENTHOL, UNSPECIFIED FORM 
METHYLPARABEN 
MINERAL OIL 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
WHITE WAX 
Product Characteristics
ColorWHITE (White ointment) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0246-251 TUBE in 1 BLISTER PACK
19 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/09/2006
Labeler - Wyeth Consumer Healthcare LLC (828831730)
Establishment
NameAddressID/FEIOperations
Fareva Richmond, Inc.969523245ANALYSIS(0573-0246), LABEL(0573-0246), MANUFACTURE(0573-0246), PACK(0573-0246), RELABEL(0573-0246), REPACK(0573-0246)

Revised: 10/2017
 
Wyeth Consumer Healthcare LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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