Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
New Wave Cleaning Solutions, LLC
TOPICAL
OTC DRUG
- for hand sanitizing to decrease bacteria on skin - recommended for repeated use
OTC monograph not final
NEW WAVE CLEANING SOLUTIONS HAND SANITIZER WIPE- BENZALKONIUM CHLORIDE CLOTH NEW WAVE CLEANING SOLUTIONS, LLC _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._ ---------- NEW WAVE CLEANING SOLUTIONS HAND SANITIZER WIPE DRUG FACTS _ACTIVE INGREDIENT_ Benzalkonium chloride 0.1% PURPOSE Antimicrobial USES: for hand sanitizing to decrease bacteria on skin recommended for repeated use WARNINGS For External use only WHEN USING THIS PRODUCT avoid contact with eyes. In case of eye contact, flush eyes with water. STOP USE AND ASK A DOCTOR if irritation or redness develops, or if 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 : remove and unfold wipe wipe hands thoroughly and allow to dry do not flush INACTIVE INGREDIENTS Water, cocamidoproyl betaine, citric acid, PACKAGE LABELING: New Wave Cleaning Solutions, LLC NEW WAVE CLEANING SOLUTIONS HAND SANITIZER WIPE benzalkonium chloride cloth PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:8 0 0 42-0 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 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX) CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:8 0 0 42- 0 0 2-0 0 10 0 in 1 BOX 0 9 /0 1/20 20 1 4 mL 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 9 /0 1/20 Preberite celoten dokument