País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Cardinal Health, 110 dba Leader
AURICULAR (OTIC)
OTC DRUG
Ear Drying Aid Dries water in the ears
OTC monograph final
LEADER EAR DROPS FOR SWIMMERS- LEADER EAR DROPS FOR SWIMMERS LIQUID CARDINAL HEALTH, 110 DBA LEADER ---------- LEADER EAR DROPS FOR SWIMMERS Isopropyl Alcohol 95% in 5% Anhydrous Glycerin Ear Drying Aid Dries water in the ears Flammable: Keep away from fire or flame Do not use in the eyes Apply 4 to 5 drops in each affected ear Store at room temperature keep tightly closed Glycerin Keep out of reach of children. in case of accidental ingestion, seek professional assitance or contact a poison control center immediately. (1-800-222-1222) LEADER EAR DROPS FOR SWIMMERS leader ear drops for swimmers liquid Cardinal Health, 110 dba Leader PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:70000-0478 ROUTE OF ADMINISTRATION AURICULAR (OTIC) ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 950 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH GLYCERIN (UNII: PDC6A3C0OX) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70000- 0478-1 30 mL in 1 CONTAINER; Type 0: Not a Combination Product 04/24/2019 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug M014 04/24/2019 LABELER - Cardinal Health, 110 dba Leader (063997360) REGISTRANT - Pharma Nobis, LLC (118564114) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Pharma Nobis, LLC 118564114 label(70000-0478) , pack(70000-0478) , manufacture(70000-0478) , analys is (70000-0478) Revised: 12/2023 Llegiu el document complet