País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Urigel
TOPICAL
OTC DRUG
Antibacterial, Hand Sanitizer For handwashing to decrease bacteria on skin. - on children less than 2 months of age - on open skin wounds - over large areas of the body or if you are allergic to any of these ingredients. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC monograph not final
ANTIBACTERIAL ALCOHOL WIPES- ALCOHOL CLOTH URIGEL _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 ALCOHOL WIPES 80U ACTIVE INGREDIENT(S) EthylAlcohol 80%. Purpose: Antibacterial PURPOS E Antibacterial, Hand Sanitizer US E For handwashing to decrease bacteria on skin. WARNINGS For external use only. Flammable. Keep away from heat or flame DO NOT USE on children less than 2 months of age on open skin wounds over large areas of the body or if you are allergic to any of these ingredients. When using this product avoid contact with eyes. If contact occurs, 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 To use, pull out wipe and reseal container to maintain moisture. Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and dispose of wipein a trash receptacle. Do not flush. Rub hands together briskly to dry. OTHER INFORMATION Store between 59-86 °F (15-30 °C) Avoid freezing and excessive heat Dispose of contents/container responsibly INACTIVE INGREDIENTS Water, Glycerin. PRINCIPAL DISPLAY PANEL 450 UNITS 80 EACH SANITIZER WIPES 80 Each NDC: 80924-110-01 100 EACH SANITIZER WIPES 100 Each NDC:80924-110-02 450 SANITIZER WIPES 450 Each NDC:80924-110-03 ANTIBACTERIAL ALCOHOL WIPES alcohol cloth PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:8 0 9 24-110 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 70 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) WATER (UNII: 0 59 QF0 KO0 R) Urige l PACKAG ING # ITEM CODE PA Leer el documento completo