País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
Chlorhexidine gluconate,( 2% solution ) , Isopropyl alcohol,( 70% solution )
Miraclean Technology Co.,Ltd
TOPICAL
OTC DRUG
■ If any open wounds ■ If package damaged or expired ■ If the patient is allergic to chlorhexidine gluconate or any other ingredient in this product Antiseptic If any irritation or allergic reaction occurs For skin preparation before surgery
OTC monograph not final
CHLORHEXIDINE GLUCONATE APPLICATOR- CHLORHEXIDINE GLUCONATE APPLICATOR SOLUTION MIRACLEAN TECHNOLOGY CO.,LTD REFERENCE LABEL SET ID: 9EE5676C-3661-44E1-E053-2995A90A9214 _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._ ---------- ACTIVE INGREDIENTS Chlorhexidine gluconate, 2% solution Isopropyl alcohol, 70% solution ASK A DOCTOR If any irritation or allergic reaction occurs DO NOT USE ■ If any open wounds ■ If package damaged or expired ■ If the patient is allergic to chlorhexidine gluconate or any other ingredient in this product KEEP OUT OF THE REACH OF CHILDREN Keep out of the reach of children PURPOS E Antiseptic STOP USE AND ASK A DOCTOR If any irritation or allergic reaction occurs INACTIVE INGREDIENT ■ Water OTHER INFORMATION ■ Stored between 4-30 Avoid exclusive heat above 40 (104° F) DIRECTIONS Peel apart the package and remove the applicator Pull and remove the ring collar lock from the handle Wet the treatment area with the fluid Press down the handle to activate and release the solution flow into the sponge pad US E For skin preparation before surgery WARNINGS ■ Single-use product ■ Keep away from flames or sparks ■ Keep out of the reach of children LABEL CHLORHEXIDINE GLUCONATE APPLICATOR chlorhexidine gluconate applicator solution PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:7356 5-0 11 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL - UNII:ND2M416 30 2) ISOPROPYL ALCOHOL 70 g in 10 0 g CHLO RHEXIDINE GLUCO NATE (UNII: MOR8 4MUD8 E) (CHLORHEXIDINE - UNII:R4KO0 DY52L) CHLORHEXIDINE GLUCONATE 2 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:7356 5-0 1 Leia o documento completo