País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Nanova Biomaterials Inc
TOPICAL
OTC DRUG
OTC monograph not final
NOVAGEL WIPES- SANITIZING WIPES LIQUID HYDRA PEARL WIPE- SANITIZING WIPE LIQUID NOVAGEL- ANTISEPTIC SPRAY SPRAY NANOVA BIOMATERIALS 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._ ---------- PRINCIPLE DISPLAY PANEL ACTIVE INGREDIENT Ethyl Alcohol 80% v/v Antiseptic PURPOSE SECTION Use - To decrease bacteria on skin KEEP OUT OF THE REACH OF CHILDREN Keep out of reach of children USE - TO DECREASE BACTERIA ON SKIN Use - To decrease bacteria on skin WARNINGS Warnings For external use only. Flammable. Keep away from fire and flame. DOSAGE Active Ingredient Ethyl Alcohol 80% v/v INACTIVE INGREDIENT SECTION Inactive Ingredients Glycerin, Water HYDRA PEARL WIPES NOVAGEL WIPES LABEL NOVAGEL WIPES sanitizing wipes liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:80947-003 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 490 mL in 700 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ALOE (UNII: V5VD430YW9) 0.35 mL in 700 mL WATER (UNII: 059QF0KO0R) 200.2 mL in 700 mL GLYCERIN (UNII: PDC6A3C0OX) 9.45 mL in 700 mL PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:80947- 003-01 700 mL in 1 CANISTER; Type 0: Not a Combination Product 03/17/2021 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph not final part333A 03/17/2021 HYDRA PEARL WIPE sanitizing wipe liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:80947-002 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 490 mL in 700 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH GLYCERIN (UNII: PDC6A3C0O Leer el documento completo