Hand Sanitizer

Manufacturer
Humble Suds, LLC
Effective date
2020-11-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:06:41

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Wet hands thoroughly with product and rub until dry. Supervise children under age of 6.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethanol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from heat or flame.

Do not use on children less than 2 months of age.

When using this product keep out of eyes. In case of contact with eyes, rinse 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 Poison Control right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and rub until dry. Supervise children under age of 6.

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

74209-001: Distilled water, vegetable glycerin, Lavendar essential oil, Lemon essential oil, Peppermint essential oil

74209-002:

Distilled water, vegetable glycerin, Grapefruit essential oil, Lemon essential oil, Lemongrass essential oil

74209-003:

Hydrogen peroxide, Distilled water, vegetable glycerin

RECENT MAJOR CHANGES SECTION

Changes 4/2020:

Warnings:

Changed: "Keep away from fire or flame" to Keep away from heat or flame"

Do not use….Added: Do not use on children less than 2 months of age.

When using this product….Changed: “Do not use in eyes. If contact occurs, flush thoroughly with water.” To “When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water.”

Stop use and ask a doctor if….Changed: “Stop use and ask doctor if redness or irritation develop and persists for more than 72 hours.” To “Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.”

Directions:

Added: “Supervise children under age of 6.”

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mL NDC: 74209-001-01

74209-001-0174209-001-01

30 mL NDC: 74209-002-01

74209-002-0174209-002-01

118 mL NDC: 74209-001-02

74209-001-0274209-001-02

118 mL NDC: 74209-002-02

74209-002-0274209-002-02

30 mL NDC: 74209-003-01

74209-003-0174209-003-01

118 mL NDC: 74209-003-02

74209-003-0274209-003-02

473 mL NDC: 74209-001-03 74209-001-0374209-001-03

473 mL NDC: 74209-002-03

74209-002-0374209-002-03

473 mL NDC: 74209-003-03

74209-003-0374209-003-03

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

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
cf1d1e0c-66fb-15df-e053-2995a90a94bda218a952-c7d5-3242-e053-2a95a90a91d22021-10-24WarningsExact identifier
spl set id: a218a952-c7d5-3242-e053-2a95a90a91d2

Reported adverse events (FAERS/openFDA)#

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