Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
KYJ Medical Products Co.,Ltd.
ISOPROPYL ALCOHOL
ISOPROPYL ALCOHOL 0.7 mL
TOPICAL
OTC DRUG
Antiseptic Use for preparation of the skin prior to an injection
OTC monograph not final
ALCOHOL PREP- ISOPROPYL ALCOHOL SWAB KYJ 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._ ---------- KYJ MEDICAL ALCOHOL PREP PAD MEDIUM STERILE ,SINGLE USE, LATEX-FREE SATURATED WITH 70% V/V ISOPROPYL ALCOHOL ACTIVE INGREDIENT Isopropyl Alcohol 70% PURPOS E Antiseptic US E Use for preparation of the skin prior to an injection WARNNING For External use only. Flammable,keep away from fire or flame. Do not use with electrocautery procedures in eyes. Stop use and ask a doctor if irritation and redness develop,condition persists for more than 72 hours . Keep out of reach of children in case of accidental ingestion,seek professional assistance or consult a Poison Control Center immediately. DIRECTIONS Apply alcohol as needed to clean intended area. Discard after single use. INACTIVE INGREDIENTS Inactive Ingredients: Purified Water Keep out of reach of children in case of accidental ingestion,seek professional assistance or consult a Poison Control Center immediately. ALCOHOL PREP isopropyl alcohol swab PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:76 16 1-0 0 1 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 0 .7 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) 0 .3 mL PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:76 16 1-0 0 1-0 1 1 in 1 PACKAGE 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 4/20 /20 11 KYJ Medical Products Co.,Ltd. LABELER - KYJ Medical Products Co.,Ltd. (421270350) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS KYJ Medical Pro d Les hele dokumentet