Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
Budpak Inc.
TOPICAL
OTC DRUG
Purpose Oral pain reliever Use temporarily relieves sore gums due to teething in infants and children 4 months and older Do not use - for more than 7 days unless told to do so by a physician - more than directed Stop using and ask a dentist or physician if - sore mouth symptoms do not get better in 7 days - irritation, pain or redness does not go away - swelling, rash or fever develops
OTC monograph not final
BUDPAK BABY TEETHING ORAL PAIN RELIEVER- BENZOCAINE GEL BUDPAK 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._ ---------- BUDPAK BABY TEETHING ORAL PAIN RELIEVER GEL _ACTIVE INGREDIENT_ Benzocaine 7.5% _PURPOSE_ Oral pain reliever _USE_ temporarily relieves sore gums due to teething in infants and children 4 months and older _WARNINGS_ ALLERGY ALERT: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. DO NOT USE for more than 7 days unless told to do so by a physician more than directed WHEN USING THIS PRODUCT fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your physician. STOP USING AND ASK A DENTIST OR PHYSICIAN IF sore mouth symptoms do not get better in 7 days irritation, pain or redness does not go away swelling, rash or fever develops KEEP OUT OF REACH OF CHILDREN. In cases of overdose or allergic reaction, get medical help or contact a Poison Control Center right away _DIRECTIONS_ do not use if tube safety seal is broken wash hands break seal on tube use your fingertip or cotton applicator to apply a small pea-size amount of Budpak Baby Teething Gel Medicine. apply to affected area up to 4 times daily or as directed by a dentist or physician. for infants under 4 months of age, ask a doctor _OTHER INFORMATION_ Store at 15°C to 25 °C (59°F to 77°F) Lot No. & Exp. Date: see crimp of tube _INACTIVE INGREDIENTS_ Glycyrrhizin Ammoniated, Glycerin, Polyethylene glycol, Purified water, Sodium saccharin, Sorbic acid, Sorbitol, Flavor, Red #40. PRINCIPAL DISPLAY PANEL BUDPAK BABY TEETHING PAIN RELIEVER GEL Benzocaine 7.5% NET WT 0.5 OZ. (14 g) BUDPAK BABY TEETHING ORAL PAIN RELIEVER benzocaine gel PRODUCT INFORMATION Budpak Inc. PRODUCT T YPE HUMAN OTC DRUG IT Citiți documentul complet