Advanced — v17

Advanced

4 Views

Version

v17

Effective date

September 26, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
3fb67af8-7135-a5ae-e063-6294a90a99a5
Set ID
faaa3452-ef1e-47db-9978-5105de69d981
Application numbers
505G(a)(3)
Product NDCs
36800-370
Package NDCs
36800-370-16, 36800-370-34, 36800-370-45
Original packager NDCs
—

Names & Manufacturers

Brand names
Advanced
Generic names
ETHYL ALCOHOL
Manufacturer names
TOPCO Assoc. LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ALCOHOL
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
581662
UNII
3K9958V90M
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Ethyl alcohol 70%
Adverse Reactions (1)

Sequence 1

Adverse event DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO VIJA0223 QUESTIONS? 1-888-423-0139 topcare@topco.com WWW.TOPCAREBRAND.COM **This product is not manufactured or distributed by GOJO Industries, Inc. distributor of Purell ® Refreshing Gel Advanced Hand Sanitizer. *Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds. DSP-TN-21091 DSP-MO-20087 DSP-MO-28 SDS-MO-20068 QUALITY GUARANTEED This TopCare ® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed. Scan here for more information or call 1-888-423-0139 Pat. 9,161,982
Dosage And Administration (1)

Sequence 1

Directions wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants
Inactive Ingredient (1)

Sequence 1

Inactive ingredients water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, carbomer or acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4
Indications And Usage (1)

Sequence 1

Uses to decrease bacteria on the skin that could cause disease recommended for repeated use
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Principal display panel TopCare ® everyday advanced hand sanitizer WITH VITAMIN E kills 99.9 of harmful germs* leaves hands feeling soft COMPARE TO PURELL ® ADVANCED HAND SANITIZER** 32 FL OZ (1 QT) 946 mL image description image description
Purpose (1)

Sequence 1

Purpose Antiseptic
Questions (1)

Sequence 1

Questions? 1-888-423-0139
Spl Product Data Elements (1)

Sequence 1

Advanced Ethyl Alcohol WATER GLYCERYL CAPRYLATE/CAPRATE GLYCERIN ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL ACETATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) SULISOBENZONE ALCOHOL ALCOHOL
Stop Use (1)

Sequence 1

Stop use and ask a doctor if ■ irritation and redness develop ■ condition persists for more than 72 hours
Storage And Handling (1)

Sequence 1

Disclaimer do not store above 105⁰F may discolor some fabrics harmful to wood finishes and plastics
Warnings (1)

Sequence 1

Warnings For external use only: hands Flammable, keep away from fire or flame.
When Using (1)

Sequence 1

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not inhale or ingest

OpenFDA raw payload

{'application_number': ['505G(a)(3)'],
 'brand_name': ['Advanced'],
 'generic_name': ['ETHYL ALCOHOL'],
 'is_original_packager': [True],
 'manufacturer_name': ['TOPCO Assoc. LLC'],
 'package_ndc': ['36800-370-34', '36800-370-16', '36800-370-45'],
 'product_ndc': ['36800-370'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['581662'],
 'spl_id': ['3fb67af8-7135-a5ae-e063-6294a90a99a5'],
 'spl_set_id': ['faaa3452-ef1e-47db-9978-5105de69d981'],
 'substance_name': ['ALCOHOL'],
 'unii': ['3K9958V90M']}