Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
ACTIVE INGREDIENTS, Benzalkonium chloride, 0.13% Benzocaine, 5%
Church & Dwight Co., Inc.
BENZALKONIUM CHLORIDE
BENZALKONIUM CHLORIDE 0.13 mg in 1 g
TOPICAL
OTC DRUG
PURPOSE Topical Antiseptic USES - to treat cold sores / fever blisters - in the eyes - over large areas of the body - if you are allergic to any ingredient in this product - more than 3 times per day - longer than one week unless directed by a physician for teething in children under 2 years of age - for teething - in children under 2 years of age - condition persists or worsens - symptoms persist for more than 7 days
OTC monograph not final
ORAJEL FOR COLD SORES SINGLE DOSE- BENZALKONIUM CHLORIDE, BENZOCAINE LIQUID CHURCH & DWIGHT CO., INC. _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._ ---------- ORAJEL COLD SORE TOUCH FREE, SINGLE DOSE ACTIVE INGREDIENTS ACTIVE INGREDIENTS Benzalkonium chloride, 0.13% Benzocaine, 5% PURPOSE PURPOSE Topical Antiseptic USES USES to treat cold sores / fever blisters WARNINGS WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. 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 beat, 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 in the eyes over large areas of the body if you are allergic to any ingredient in this product more than 3 times per day longer than one week unless directed by a physician for teething in children under 2 years of age STOP USE AND ASK A DENTIST OR PHYSICIAN IF condition persists or worsens symptoms persist for more than 7 days ASK A PHYSICIAN IF used to treat deep or puncture wounds, animal bites, or serious burns you are pregnant or nursing a baby WHEN USING THIS PRODUCT You may feel a brief stinging sensation when you apply it. The sting should go away in a short time. KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away. DIRECTIONS DIRECTIONS • Slide-off to re Lees het volledige document