Promise U 70% Ethyl Alcohol Topical Hand Sanitizer Spray

Manufacturer
Promise U LLC | Promise U Labs
Effective date
2022-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:55:29

Label at a glance#

ProductPromise U
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(s) Ethyl Alcohol 70% v/v

INACTIVE INGREDIENT SECTION

Inactive ingredients: glycerin, hydrogen peroxide, and purified water USP

OTC - PURPOSE SECTION

Purpose.......................................................Antiseptic

INDICATIONS & USAGE SECTION

Use(s) Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

DOSAGE & ADMINISTRATION SECTION

Spray enough product on hands to cover all surfaces. Rub hands together until dry.

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 at 1-800-222-1222. Supervise children under 6 years of age when using this product to avoid swallowing.

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 at 1-800-222-1222. For external use only. Flammable. Keep
away from heat or flame. Do not use on children less than 2 months of age and on open skin wounds.

Directions • 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 • Store between 15-30C (59-86F)

OTC - ASK DOCTOR SECTION

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 at 1-800-222-1222.

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame. Do not use on children less than 2 months of age and on open skin
wounds. 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 at 1-800-222-1222.

Supervise children under 6 years of age when using this product to avoid swallowing. Other information • Store between 15-30C (59-86F) • Avoid freezing and excessive heat above 40C (104F)

Promise U's Product Label & Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Promise U's Product Label and Drug FactsPromise U's Product Label and Drug Facts

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82674-00782674-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
dc276bcb-9ed8-0be3-e053-2995a90a9753dc276bcb-9ed8-0be3-e053-2995a90a97532022-04-08WarningsExact identifier
spl id: dc276bcb-9ed8-0be3-e053-2995a90a9753
spl set id: dc276bcb-9ed8-0be3-e053-2995a90a9753

Reported adverse events (FAERS/openFDA)#

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