Country: United States
Language: English
Source: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Owens & Minor, Inc
ISOPROPYL ALCOHOL
ISOPROPYL ALCOHOL 70 mL in 100 mL
TOPICAL
OTC DRUG
For preparation of skin prior to injection.
OTC monograph not final
MEDICHOICE ANTISEPTIC ISOPROPYL ALCOHOL PREP PADS- ISOPROPYL ALCOHOL SWAB OWENS & MINOR, INC ---------- MEDICHOICE ANTISEPTIC ISOPROPYL ALCOHOL PREP PADS _DRUG FACTS_ ACTIVE INGREDIENT Isopropyl Alcohol, 70% v/v _PURPOSE_ Antiseptic USE For preparation of skin prior to injection. WARNINGS FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. DO NOT USE with electrocautery procedures in the eyes. on mucous membranes on irritated skin. STOP USE AND ASK A DOCTOR IF irritation and redness develops 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 15-30ºC (59-86ºF) INACTIVE INGREDIENT Purified Water PACKAGE LABELING: (39892-0100-1) PACKAGE LABELING: (39892-0100-2) PACKAGE LABELING: (39892-0100-3) MEDICHOICE ANTISEPTIC ISOPROPYL ALCOHOL PREP PADS isopropyl alcohol swab PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:39892-0100 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) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:39892- 0100-1 4000 in 1 CASE 09/20/2012 1 0.57 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:39892- 0100-2 1000 in 1 CASE 09/20/2012 2 0.91 mL in 1 PACKET; Type 0: Not a Combination Product NDC:39892- Owens & Minor, Inc 3 NDC:39892- 0100-3 4000 in 1 CASE 09/20/2012 3 0.4 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 M003 09/20/2012 LABELER - Owens & Minor, Inc (847412269) REGISTRANT - Owens & Minor, Inc (847412269) Revised: 12/2023 Read the complete document