FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Pristine LLC
Effective date
2021-05-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:44:35

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

Active IngredientActive IngredientAlcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • Do not use in children less than 2 months of age on open skin woundsDo not use in children less than 2 months of age on open skin wounds

OTC When Using

OTC - WHEN USING SECTION

When using keep out of eyes ears...When using keep out of eyes ears...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.

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • DirectionsDirectionsPlace 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

  • Storage and Other InformationStorage and Other InformationStore between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP, bubblegum fragrance inactive ingredientsinactive ingredients

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 80083

Distributed by Pristine LLC 2415 West Alabama Street, Ste 200, Houston, TX 77098. Info@cobalt-clean.com NDC Labeler Code 80083

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Package LabelPackage Label

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80083-00280083-002-01, 80083-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BITTER ORANGE OIL9TLV70SV6IIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
c2c64f7e-cd75-1469-e053-2a95a90a3687aefce1a1-b97a-7d92-e053-2a95a90af1712021-05-20WarningsExact identifier
spl id: c2c64f7e-cd75-1469-e053-2a95a90a3687
spl set id: aefce1a1-b97a-7d92-e053-2a95a90af171

Reported adverse events (FAERS/openFDA)#

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