País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M), ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Klenlii Company
TOPICAL
OTC DRUG
ANTISEPTIC - DECREASE BACTERIA ON SKIN
OTC monograph not final
KLENLII HAND SANII ALCOHOL SANITIZER- ETHYL ALCOHOL, ISOPROPYL ALCOHOL SPRAY KLENLII COMPANY _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._ ---------- KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107) ACTIVE INGREDIENT ETHYL ALCOHOL 63% ISOPROPYL ALCOHOL 7% PURPOSE ANTISEPTIC USES DECREASE BACTERIA ON SKIN WARNINGS FOR EXTERNAL USE ONLY: HANDS FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. WHEN USING THIS PRODUCT KEEP OUT OF EYES STOP USE AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. DIRECTIONS THOROUGHLY WET HANDS WITH PRODUCT AND ALLOW TO DRY INACTIVE INGREDIENTS DEIONIZED WATER, GLYCERIN KLENLII HAND SANII ALCOHOL SANITIZER ethyl alcohol, isopropyl alcohol spray PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:78016-107 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 63 mL in 100 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 7 mL in 100 mL Klenlii Company INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:78016- 107-18 238 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2020 2 NDC:78016- 107-14 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 05/27/2020 3 NDC:78016- 107-16 476 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2020 4 NDC:78016- 107-11 3785 mL in 1 JUG; Type 0: Not a Combination Product 05/27/2020 5 NDC:78016- 107-12 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2020 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH C Leia o documento completo