Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Urigel Inc.
TOPICAL
OTC DRUG
For hand washing to decrease bacteria on the skin
OTC monograph not final
URIGEL NEUTRO ANTISEPTIC HAND SANITIZE 75%R 75%- ALCOHOL GEL URIGEL 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._ ---------- URIGEL NEUTRO ANTISEPTIC HAND SANITIZER 75% _DRUG FACTS_ _ACTIVE INGREDIENT_ Ethyl Alcohol 75% _PURPOSE_ Antiseptic _USE_ For hand washing to decrease bacteria on the skin _WARNINGS_ FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME. DO NOT USE in the eyes. STOP USE AND ASK A DOCTOR IF: irritation and redness develop. condition persists for more than 72 hours. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ Wet hands thoroughly with product and allow to dry without wiping. _OTHER INFORMATION_ Store between 59-86°F (15-30°C) Avoid freezing and excessive heat above 104°F (40°C) _INACTIVE INGREDIENTS_ Glycerin, hydrogen peroxide, water, paraffin, carbopol 940 PACKAGE LABELING: 3.75ML/! Gal NDC 80924-0 03-10 URIGEL NEUTRO ANTISEPTIC HAND SANITIZE 75%R 75% alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:8 0 9 24-0 0 3 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 GLYCERIN (UNII: PDC6 A3C0 OX) Urigel Inc. HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V) WATER (UNII: 0 59 QF0 KO0 R) PARAFFIN (UNII: I9 O0 E3H2ZE) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:8 0 9 24-0 0 3-10 3750 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 11/0 1/20 20 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt333E 11/0 1/20 20 LABELER - Urigel Inc. (117688244) REGISTRANT - Urig Aqra d-dokument sħiħ