FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Elemental Herbs, Inc. | Evergreen Innovations LLC
Effective date
2022-05-18
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 23:49:37

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

All good organic peppermintAll good organic peppermintThrive organic HSThrive organic HS2021 Update2021 UpdateGrove Hand Sanitizer Gel Blood Orange BackGrove Hand Sanitizer Gel Blood Orange BackGrove Hand Sanitizer Gel Blood Orange FrontGrove Hand Sanitizer Gel Blood Orange FrontAll Good Organic Peppermint Spray 2 fl oz (REI)All Good Organic Peppermint Spray 2 fl oz (REI)All Good Peppermint Hand Sanitizer 2 fl oz (Thyme)All Good Peppermint Hand Sanitizer 2 fl oz (Thyme)All Good Hand Sanitizer Gel 2 fl oz UnscentedAll Good Hand Sanitizer Gel 2 fl oz UnscentedAll Good Peppermint Hand Sanitizer 2.0 fl ozAll Good Peppermint Hand Sanitizer 2.0 fl ozAll Good Peppermint Hand Sanitizer 2.7 fl ozAll Good Peppermint Hand Sanitizer 2.7 fl oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN11
1041849ethanol 70 % Topical SprayPSN11
581660ethanol 0.62 ML/ML Topical GelSCD11
1041849ethanol 0.7 ML/ML Topical SpraySCD11
581660ethanol 62 % Topical GelSY11
1041849ethanol 70 % Topical SpraySY11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75786-102-552024-01-30C16284748780-11030e365-0acf-111a-e063-dadaa90a10e2Hand Sanitizer
75786-102-562024-01-30C16284748780-11030e365-0acf-111a-e063-dadaa90a10e2Hand Sanitizer
75786-106-572024-01-30C16284748780-11030e365-0acf-111a-e063-dadaa90a10e2Hand Sanitizer
75786-107-592024-01-30C16284748780-11030e365-0acf-111a-e063-dadaa90a10e2Hand Sanitizer
75786-107-642024-01-30C16284748780-11030e365-0acf-111a-e063-dadaa90a10e2Hand Sanitizer
75786-108-602024-01-30C16284748780-11030e365-0acf-111a-e063-dadaa90a10e2Hand Sanitizer
75786-111-612024-01-30C16284748780-11030e365-0acf-111a-e063-dadaa90a10e2Hand Sanitizer
75786-112-632024-01-30C16284748780-11030e365-0acf-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75786-102-55Hand Sanitizer80 mL in 1 BOTTLE, SPRAYLIQUID8011
75786-102-56Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID6011
75786-106-57Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID6011
75786-107-59Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID6011
75786-107-64Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID6011
75786-108-60Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID6011
75786-111-61Hand Sanitizer59.1 mL in 1 BOTTLE, PLASTICLIQUID59.111
75786-112-63Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75786-102HAND SANITIZER (ALCOHOL) LIQUID HAND SANITIZER (ALCOHOL) LIQUID [ELEMENTAL HERBS, INC.]11Legacy NDC, 2 package rows20220519_a488c76d-2c36-7a4c-e053-2995a90a6382.zip
75786-106HAND SANITIZER (ALCOHOL) LIQUID HAND SANITIZER (ALCOHOL) LIQUID [ELEMENTAL HERBS, INC.]11Legacy NDC, 1 package rows20220519_a488c76d-2c36-7a4c-e053-2995a90a6382.zip
75786-107HAND SANITIZER (ALCOHOL) LIQUID HAND SANITIZER (ALCOHOL) LIQUID [ELEMENTAL HERBS, INC.]11Legacy NDC, 2 package rows20220519_a488c76d-2c36-7a4c-e053-2995a90a6382.zip
75786-108HAND SANITIZER (ALCOHOL) LIQUID HAND SANITIZER (ALCOHOL) LIQUID [ELEMENTAL HERBS, INC.]11Legacy NDC, 1 package rows20220519_a488c76d-2c36-7a4c-e053-2995a90a6382.zip
75786-111HAND SANITIZER (ALCOHOL) LIQUID HAND SANITIZER (ALCOHOL) LIQUID [ELEMENTAL HERBS, INC.]11Legacy NDC, 1 package rows20220519_a488c76d-2c36-7a4c-e053-2995a90a6382.zip
75786-112HAND SANITIZER (ALCOHOL) LIQUID HAND SANITIZER (ALCOHOL) LIQUID [ELEMENTAL HERBS, INC.]11Legacy NDC, 1 package rows20220519_a488c76d-2c36-7a4c-e053-2995a90a6382.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75786-10275786-102-55, 75786-102-56
75786-10675786-106-57
75786-10775786-107-59, 75786-107-64
75786-10875786-108-60
75786-11175786-111-61
75786-11275786-112-63

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
JOJOBA OIL724GKU717MIACT
ALOEV5VD430YW9IACT
ORANGE OILAKN3KSD11BIACT
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PEPPERMINT OILAV092KU4JHIACT
THYMUS VULGARIS LEAFGRX3499643IACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
TOCOPHEROLR0ZB2556P8IACT
PEPPERMINT OILAV092KU4JHIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)3A1I7376TCIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHAMOMILEFGL3685T2XIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
THYMUS VULGARIS LEAFGRX3499643IACT
PEPPERMINT OILAV092KU4JHIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
THYMUS VULGARIS LEAFGRX3499643IACT

Source Document#

Source XML · Source PDF

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
df4e5a48-eb0c-fe3d-e053-2a95a90aa967a488c76d-2c36-7a4c-e053-2995a90a63822022-05-18WarningsExact identifier
spl id: df4e5a48-eb0c-fe3d-e053-2a95a90aa967
spl set id: a488c76d-2c36-7a4c-e053-2995a90a6382

Reported adverse events (FAERS/openFDA)#

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