FDA.reportPublic FDA data

GeriGentle Antimicrobial Alcohol Gel Hand Wipes

Manufacturer
Geri-Gentle Corporation
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:59:48

Label at a glance#

ProductGeriGentle Hand Wipes
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Antiseptic. For hand washing to decrease bacteria on the skin, after assisting ill persons and before contact with a person under medical care or treatment. Apply topically to the skin to help prevent cross contamination. Recommended for repeated use. Dries in seconds

Dosage and administration

To start the feed of the wipes: Remove cover and discard seal from container, from the center of the towel roll pull up the corner of the wipe and tear off that wipe. Twist the next wipe into a point and thread through the hole in the container cover. Pull through only about one inch. Replace the cover, pull up wipes as needed and snap off at 90 angle. Keep cover closed to prevent moisture loss. 0 Wipe hands, fin...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                        Purpose Alcohol 65.9% by volume           Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Antiseptic.
  • For hand washing to decrease bacteria on the skin, after assisting ill persons and before contact with a person under medical care or treatment.
  • Apply topically to the skin to help prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds

Warnings

WARNINGS SECTION

  • Flammable, keep away from fire or flame.
  • For external use only.

Do Not Use

OTC - DO NOT USE SECTION

  • DO NOT USE

in or contact the eye

Stop Use

OTC - STOP USE SECTION

  • Discontinue Use

if irritation and redness develop, If condition persists for more than 72 hours consult a physician.

Directions

DOSAGE & ADMINISTRATION SECTION

  • To start the feed of the wipes: Remove cover and discard seal from container, from the center of the towel roll pull up the corner of the wipe and tear off that wipe. Twist the next wipe into a point and thread through the hole in the container cover. Pull through only about one inch. Replace the cover, pull up wipes as needed and snap off at 90 angle. Keep cover closed to prevent moisture loss. 0
  • Wipe hands, fingers, inter-digital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipes surface. Allow to dry.
  • If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe, sanitize with a second wipe.
  • Discard after single use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe Barbadensis Leaf Juice, Carbomer, Glycerin, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolamine, Water.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of Children

  • Unless under adult supervision,
  • If swallowed, get medical help or contact the Poison Control Center

Other Information

SPL UNCLASSIFIED SECTION

Lot No. and Expiration Date can be found on the canister

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 44

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654645ethanol 69.5 % Medicated PadPSN5
1654645ethanol 0.695 ML/ML Medicated PadSCD5
1654645ethanol 69.5 % Gel Hand WipesSY5
1654645ethanol 69.5 % Medicated PadSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-001-012023-02-08C16284748780-19d75b9d0-45d0-f424-e053-dadaa90a57ceGeriGentle Antimicrobial Alcohol Gel Hand Wipes
69771-001-012020-01-31C16284748780-19d75b9d0-45d0-f424-e053-dadaa90a57ceGeriGentle Antimicrobial Alcohol Gel Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-001-01GeriGentle Hand Wipes3.42 g in 1 PATCHGEL3.425
69771-001-01GeriGentle Hand Wipes135 in 1 CANISTERGEL1355

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-001GERIGENTLE HAND WIPES (ALCOHOL) GEL [GERI-GENTLE CORPORATION]5Current NDC, Legacy NDC, 2 package rows20231111_278b23f5-c3bd-48ae-8c8d-d537d521e0a4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
CARBOMER 934INACTIVE INGREDIENTZ135WT92081
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-00169771-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 934Z135WT9208IACT
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE SODIUMMP1J8420LUIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208GEL / TOPICAL30 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208GEL / TOPICAL30 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GeriGentle Hand WipesALCOHOLGeri-Gentle Corporation278b23f5-c3bd-48ae-8c8d-d537d521e0a42023-11-10WarningsExact identifier
ndc (package): 69771-001-01
ndc (product): 69771-001
ndc11 (package): 69771000101
spl id: 09cc2f82-4eef-753a-e063-6294a90a8644
spl set id: 278b23f5-c3bd-48ae-8c8d-d537d521e0a4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.