ANBESOL COLD SORE THERAPY- allantion, benzocaine, camphor, petrolatum ointment

ANBESOL COLD SORE THERAPY by

Drug Labeling and Warnings

ANBESOL COLD SORE THERAPY by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Warnings

METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. 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
• on animal bites
• on serious burns
• for teething
• in children under age 2

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: do not use

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

Anbesol®
Cold Sore THERAPY

MAXIMUM STRENGTH

Fever Blister/
Cold Sore
Treatment

ointment

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.

INGREDIENTS AND APPEARANCE

ANBESOL COLD SORE THERAPY 
allantion, benzocaine, camphor, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0246
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	10 mg  in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	649 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	WHITE (White ointment)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0246-25	1 in 1 BLISTER PACK	05/09/2006	06/21/2010
1		9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0573-0246-26	1 in 1 BLISTER PACK	09/15/2008
2		9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/09/2006

Labeler - Wyeth Consumer Healthcare LLC (828831730)