Country: United States
Language: English
Source: NLM (National Library of Medicine)
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)
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
ALLANTOIN
ALLANTOIN 10 mg in 1 g
TOPICAL
OTC DRUG
- temporarily relieves pain associated with fever blisters and cold sores - relieves dryness and softens fever blisters and cold sores
OTC monograph not final
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