Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Dynarex Corporation
TOPICAL
OTC DRUG
First Aid Antiseptic • For perineal and maternity care throughout postpartum and whenever refreshing is needed.
OTC monograph not final
BZK PADS- BENZALKONIUM CHLORIDE SWAB DYNAREX CORPORATION _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._ ---------- 1302 CLEANSING TOWELETTES NDC 67777-244-01 _ACTIVE INGREDIENT_ Benzalkonium Chloride 0.13% v/v _PURPOSE_ First Aid Antiseptic _USES_ • For perineal and maternity care throughout postpartum and whenever refreshing is needed. _WARNINGS_ FOR EXTERNAL USE ONLY _DO NOT USE_ • In the eye _STOP USE AND ASK A DOCTOR IF_ • Irritation and redness develop • If condition persists for gets worse _KEEP OUT OF REACH OF CHILDREN_ If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. _DIRECTIONS_ • Unfold towel • Cleanse the desired area • Dispose of towlette after single use. _OTHER INFORMATION_ • Store at room temperature 15º-30ºC (59º-86ºF) • Avoid excessive heat. • Tamper evident. Do not use if packet is torn or cut. _INACTIVE INGREDIENTS_ Chlorothymol, Isopropyl Acohol, Water, may contain Methylchloroisothiazolinone/Methylisothiazolinone _LABEL_ 1302 Label _LABEL_ 1302 Obstetrical Towelette BZK PADS benzalkonium chloride swab PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:67777-244 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZ ALKONIUM CHLORIDE 1.3 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) CHLOROTHYMOL (UNII: LJ25TI0CVT) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) Dynarex Corporation PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:67777-244- 01 10 in 1 CASE 04/05/2011 1 NDC:67777-244- 02 100 in 1 BOX 1 0.55 mL in 1 PACKET; Type 0: Not a Combination Product MARKETING INFORMATION MA read_full_document