Home NDC 90082-562 Hand Sanitizer
Product NDC 90082-562
11-digit product format 900820562
Labeler code 90082
Product ID 90082-562_f0457b77-bf29-0934-e053-2a95a90a89e9
Type HUMAN OTC DRUG
Nonproprietary name Isopropyl Alcohol
Dosage form GEL
Route TOPICAL
Labeler First Galaxy Enterprises Inc
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2022-12-20
Marketing end 0000-00-00
Substance ISOPROPYL ALCOHOL
Active strength 75 mL/100mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only. Flammable. Keep away from heat or flame. Do not use on children less than 2 months of age. on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 90082-562-02 Hand Sanitizer 59 mL in 1 BOTTLE GEL 59 5 90082-562-04 Hand Sanitizer 118 mL in 1 BOTTLE GEL 118 5 90082-562-08 Hand Sanitizer 237 mL in 1 BOTTLE, PUMP GEL 237 5 90082-562-16 Hand Sanitizer 473 mL in 1 BOTTLE, PUMP GEL 473 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 90082-562 HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [FIRST GALAXY ENTERPRISES INC] 5 Legacy NDC, 4 package rows 20221221_b8cd4477-bc2d-03b3-e053-2995a90a868f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 90082-562-02 90082056202 59 mL in 1 BOTTLE (90082-562-02) 59 ml 2021-01-13 0000-00-00 No No Current 90082-562-04 90082056204 118 mL in 1 BOTTLE (90082-562-04) 118 ml 2021-01-13 0000-00-00 No No Current 90082-562-08 90082056208 237 mL in 1 BOTTLE, PUMP (90082-562-08) 237 ml 2021-10-18 0000-00-00 No No Current 90082-562-16 90082056216 473 mL in 1 BOTTLE, PUMP (90082-562-16) 473 ml 2021-01-13 0000-00-00 No No Current