Country: United States
Language: English
Source: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Dukal Corporation
TOPICAL
OTC DRUG
Use For Preparation of Skin prior to an injection Do Not Use - with electrocautery procedures - In the Eyes. If contact occurs, flush eyes with water Stop Use If irritation and redness develop. If condition persists, consult your health care practitioner. Directions Wipe injection site vigorously and discard.
OTC monograph not final
DUKAL STERILE ALCOHOL PREP PAD- ISOPROPYL ALCOHOL SWAB DUKAL 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._ ---------- DRUG FACTS ACTIVE INGREDIENTS Isopropyl Alcohol 70% PURPOS E Antiseptic Cleanser US E For Preparation of Skin prior to an injection WARNINGS For External Use Only Flammable, Keep away from fire or flame DO NOT USE with electrocautery procedures In the Eyes. If contact occurs, flush eyes with water STOP USE If irritation and redness develop. If condition persists, consult your health care practitioner. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Wipe injection site vigorously and discard. Other Information Store at Room Temperature 15 - 30 C (59 - 86 F) INACTIVE INGREDIENT purified water Dukal Corporation REF 861 NDC 65517-0002-2 Sterile ALCOHOL PREP PAD Saturated with 70% Isopropyl Alcohol For External Use Only Sterility guaranteed unless package is damaged or opened. Latex 2 1 / Pouch Manufactured For: Dukal Corporation Ronkonkoma, NY 11779 631-656-3800 www.dukal.com Made in China DUKAL STERILE ALCOHOL PREP PAD isopropyl alcohol swab PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 5517-0 0 0 2 ROUTE OF ADMINISTRATION TOPICAL Dukal Corporation 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 in 1 mL 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:6 5517-0 0 0 2-2 1 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 1/20 0 0 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 Read the complete document