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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Buy It Now

Active ingredient:

ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z), BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

Available from:

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

INN (International Name):

ALLANTOIN

Composition:

ALLANTOIN 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves pain associated with fever blisters and cold sores - relieves dryness and softens fever blisters and cold sores

Authorization status:

OTC monograph not final

Summary of Product characteristics

                                ANBESOL COLD SORE THERAPY- ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM
OINTMENT
GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC
_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._
----------
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Allantoin 1%
Benzocaine 20%
Camphor 3%
White petrolatum 64.9%
_PURPOSES_
Skin protectant
Fever blister/cold sore treatment
Fever blister/cold sore treatment
Skin protectant
_USES_
1.
2.
_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:
1.
2.
3.
4.
5.
6.
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.
temporarily relieves pain associated with fever blisters and cold
sores
relieves dryness and softens fever blisters and cold sores
pale, gray, or blue colored skin (cyanosis)
headache
rapid heart rate
shortness of breath
dizziness or lightheadedness
fatigue or lack of energy
DO NOT USE
1.
2.
3.
4.
5.
WHEN USING THIS PRODUCT
1.
2.
STOP USE AND ASK A DOCTOR IF
1.
2.
3.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
_DIRECTIONS_
1.
2.
3.
4.
_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 BLISTER PACK LABEL
ointment
WITH
Vitamin E
& Aloe
Se
                                
                                Read the complete document