Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Wuhan Zonsen Medical Products Co., Ltd.
TOPICAL
OTC DRUG
Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water.
OTC monograph not final
ZONSEN BZK ANTISEPTIC- BENZALKONIUM CHLORIDE SWAB WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD. _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._ ---------- ZONSEN BZK ANTISEPTIC TOWELETTE _DRUG FACTS_ _ACTIVE INGREDIENTS_ Benzalkonium Chloride 0.133% _PURPOSE_ First Aid Antiseptic _USE_ Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water. _WARNINGS_ For external use only. DO NOT USE in the eyes. If this happens, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop and 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_ Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping. _OTHER INFORMATION_ Store at room temperature 15°C-30°C(59°F-86°F) _INACTIVE INGREDIENTS:_ purified water, sodium bicarbonate PACKAGE LABELING: ZONSEN BZK ANTISEPTIC benzalkonium chloride swab PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:729 32-0 0 2 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 1.33 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:729 32-0 0 2-0 0 1 in 1 POUCH 0 4/0 1/20 19 1 1.5 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct 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 0 4/0 1/20 19 Wuhan Zonsen Medical Products Co., Ltd. LABELER - Wuhan Zonsen Medical Products Co., Ltd. (554474517) Διαβάστε το πλήρες έγγραφο