Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Global-C Nederland B.V.
TOPICAL
OTC DRUG
For hand washing to decrease bacteria on the skin
OTC monograph not final
ANTISEPTIC TOWEL BENZALKONIUM CHLORIDE- BENZALKONIUM CHLORIDE CLOTH GLOBAL-C NEDERLAND B.V. _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._ ---------- ANTISEPTIC TOWEL BENZALKONIUM CHLORIDE _DRUG FACTS_ _ACTIVE INGREDIENT_ Benzalkonium Chloride 0.1% _PURPOSE_ Antiseptic _USE_ For hand washing to decrease bacteria on the skin _WARNINGS_ FOR EXTERNAL USE ONLY. AVOID ANY CONTACT WITH EYES, EARS OR MOUTH. Should accidental contact with eyes occur, rinse eyes thoroughly wiht water 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 below 77 °F (25 °C) _INACTIVE INGREDIENTS_ cellulose fiber, polyester, water PACKAGE LABELING: ANTISEPTIC TOWEL BENZALKONIUM CHLORIDE benzalkonium chloride cloth PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:78 6 57-0 0 6 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 1 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH PO WDERED CELLULO SE (UNII: SMD1X3XO9 M) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:78 6 57- 0 0 6 -0 1 1 in 1 PACKAGE 0 8 /13/20 20 1 3 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 rt333E 0 8 /13/20 20 Global-C Nederland B.V. LABELER - Global-C Nederland B.V. (386762558) Revised: 8/2020 Đọc toàn bộ tài liệu