Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
LernaPharm Loris Inc.
TOPICAL
OTC DRUG
Antiseptic For preparation of the skin prior to an injection. Helps reduce bacteria that potentially can cause skin infection.
OTC monograph not final
ISOPROPYL ALCOHOL PREP PAD- ISOPROPYL ALCOHOL SWAB LERNAPHARM LORIS INC. ---------- DRUG FACTS ACTIVE INGREDIENT (IN EACH SWAB) Isopropyl Alcohol 70%v/v PURPOSE Antiseptic USES For preparation of the skin prior to an injection. Helps reduce bacteria that potentially can cause skin infection. WARNINGS FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. Do not use with electrocautery procedures. FOR EXTERNAL USE ONLY. Do not use in the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Tear open individual swab and apply product to the injection site prior to an injection. Rub skin briskly in circular motion from injection site outward. OTHER INFORMATION Store at room temperature between 59 - 86 F (15 - 30 C) INACTIVE INGREDIENTS Purified water QUESTIONS OR COMMENTS? Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST 0 0 PRINCIPAL DISPLAY PANEL NDC: 68356-103-03 Product No. 103-03U Antiseptic Isopropyl Alcohol Pad LORIS Antiseptic Non-Sterile Solution and Swab 200 Units ISOPROPYL ALCOHOL PREP PAD isopropyl alcohol swab PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:68356-103 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) LernaPharm Loris Inc. PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:68356- 103-03 200 in 1 BOX 01/10/2015 1 0.238 mL in 1 PACKET; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug 505G(a)(3) 01/10/2015 LABELER - LernaPharm Loris Inc. (206940905) REGISTRANT - LernaPharm Loris Inc. (206940905 Baca dokumen lengkap