Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Calego International Inc.
TOPICAL
OTC DRUG
For handwashing to decrease bacteria on the skin.
OTC monograph not final
ANTIBACTERIAL HAND SANITIZER- ALCOHOL GEL CALEGO INTERNATIONAL 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._ ---------- ANTIBACTERIAL HAND SANITIZER _DRUG FACTS_ _ACTIVE INGREDIENT_ Alcohol 75% v/v _PURPOSE_ Antiseptic _USE_ For handwashing to decrease bacteria on the skin. _WARNINGS_ FOR EXTERNAL USE ONLY. FLAMMBLE. KEEP AWAY FROM HEAT OR FLAME. DO NOT USE on children less than 24 months of age on open skin wounds WHEN USING THIS PRODUCT keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR if irritation or rash occurs. These may be signs of a serious condition. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ Put enough gel in your palm to cover hands and rub hands together rapidly until dry. Children under 6 years of age should be supervised when using this product. _OTHER INFORMATION_ Store between 15-30C (59-86F) Avoid freezing and excessive heat above 35C(95F) _INACTIVE INGREDIENTS_ Aqua, Carbomer, Triethanolamine PACKAGE LABELING: ANTIBACTERIAL HAND SANITIZER alcohol gel Calego International Inc. PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:7248 7-0 0 9 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 0 .75 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC) TRO LAMINE (UNII: 9 O3K9 3S3TK) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:7248 7-0 0 9 -0 0 30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 5/0 1/20 20 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CIT Lestu allt skjalið