MedPath

Advanced Hand Sanitizer

Paperbird 370.001/370AE rev 1 Advanced Hand Sanitizer

Approved
Approval ID

9859ef63-70a7-4986-ad22-0c1c7333c6cb

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

Wakefern Food Corp.

DUNS: 069722418

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41190-370
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (8)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERYL CAPRYLATE/CAPRATEInactive
Code: G7515SW10N
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 809Y72KV36
Classification: IACT
SULISOBENZONEInactive
Code: 1W6L629B4K
Classification: IACT
ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/26/2025

principal display panel

A SHOPRITE ®BRAND

paperbird™

Hand Sanitizer

advanced formula

QUALITY ASSURED

KILLS MORE THAN 99.99% OF GERMS*

With moisturizers

NET 8 FL OZ (236 mL)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/26/2025

Uses

  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/26/2025

Active Ingredient

Ethyl alcohol 70%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/26/2025

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/26/2025

Warnings

For external use only: hands

Flammable, keep away from fire or flame.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/26/2025

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/26/2025

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/26/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/26/2025

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/26/2025

Other information

  • do not store above 105⁰ F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/26/2025

Inactive ingredients

water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/26/2025

Questions?

Call 1-800-746-7748

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/26/2025

PAPERBIRD IS TRADEMARKED AND DISTRIBUTED BY:

WAKEFERN FOOD CORP., 5000 RIVERSIDE DRIVE, KEASBEY, NJ 08832

2023

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