MedPath

Advanced Hand Sanitizer

CVS 439.001/439AC Advanced Hand Sanitizer with Aloe

Approved
Approval ID

2adb16b7-c43f-49a0-9a56-fece3d730089

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

CVS Pharmacy, Inc

DUNS: 062312574

Products 1

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

Ethyl Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59779-070
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (12)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
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 HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)Inactive
Code: 8Z5ZAL5H3V
Classification: IACT
SULISOBENZONEInactive
Code: 1W6L629B4K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

Principal display panel

CVS Health ®

Hand Sanitizer

WITH ALOE VERA

  • Fast & effective*
  • Moisturizing formula with vitamin E leaves hands feeling soft
  • Paraben & phthalate free

KILLS 99.99% OF GERMS*

2 FL OZ (59 mL)

image description

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

Uses

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/20/2025

Adverse reaction

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2023 CVS/Pharmacy

CVS.com 1-800-SHOP CVS

Made in the U.S.A. with U.S. and foreign components

100% money back guaranteed.

CVS.com/returnpolicy

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2025

Active ingredient

Ethyl alcohol 70%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2025

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

Warnings

For external use only-hands

Flammable, keep away from fire or flame.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/20/2025

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: 8/20/2025

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: 8/20/2025

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: 8/20/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/20/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/20/2025

Inactive ingredients

water, Aloe barbadensis leaf juice, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, carbomer or acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4, blue 1, yellow 5

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/20/2025

Claim

*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

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