Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Calego International Inc.
TOPICAL
OTC DRUG
- for handwashing to decrease bacteria on the skin.
OTC monograph not final
IFLY SMART ANTISEPTIC HAND- BENZALKONIUM CHLORIDE SWAB 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._ ---------- IFLY SMART ANTISEPTIC HAND WIPES _DRUG FACTS_ _ACTIVE INGREDIENT_ Benzalkonium Chloride 0.13% _PURPOSE_ Antiseptic _USE_ for handwashing to decrease bacteria on the skin. _WARNINGS_ FOR EXTERNAL USE ONLY. 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. _INACTIVE INGREDIENTS_ Aloe Barbadensis Leaf Juice, Glycerin, Polysorbate 20, Water PACKAGE LABELING: NEW LABELING: IFLY SMART ANTISEPTIC HAND benzalkonium chloride swab PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:7248 7-0 0 3 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6 JUD5X6 Y) BENZALKONIUM CHLORIDE 0 .13 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) GLYCERIN (UNII: PDC6 A3C0 OX) PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH) WATER (UNII: 0 59 QF0 KO0 R) Calego International Inc. WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:7248 7- 0 0 3-0 8 8 in 1 BAG 10 /0 1/20 18 1 2.6 76 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 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 rt333A 10 /0 1/20 18 LABELER - Calego International Inc. (081320445) Revised: 9/2020 Lestu allt skjalið