FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2021-08-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:42:10

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Use enough product in your palm to cover hands and rub hands together biskly until dry. Children under 6 years of age should be supervised when using this product. Identifying number of subsection is 9. change incorporated in the label 04/2021.

Storage and handling

Store below 110F (43C) May discolor fabrics or surfaces

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Aloe Barbadenis Leaf Juice.
  3. Caprylyl Glycol.
  4. Glycerin.
  5. Phenoxyethanol.
  6. Polysorate-20.
  7. Purified Water.
  8. Tocopheryl Acetate.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

SD Alcohol 40 75%

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Use

RECENT MAJOR CHANGES SECTION

subsection identifying number is Sequence 4.

change incorporated in the label on 4/2021.

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughtly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use enough product in your palm to cover hands and rub hands together biskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Directions

RECENT MAJOR CHANGES SECTION

Identifying number of subsection is 9.

change incorporated in the label 04/2021.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)
  • May discolor fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Fragrance, Glycerin, Phenoxyethanol, Polysorbate-20, Purified Water, Tocopheryl Acetate.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 mL NDC:58133-959-16

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286295ethanol 75 % Topical SprayPSN6
2286295ethanol 0.75 ML/ML Topical SpraySCD6
2286295ethanol 75 % Topical SpraySY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-959-162024-01-30C16284748780-11030e365-36b1-111a-e063-dadaa90a10e2bf3eceb7-aed8-337b-e053-2995a90ace41

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-959-16Hand Sanitizer15 mL in 1 BOTTLE, PUMPAEROSOL, SPRAY156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-959HAND SANITIZER (ALCOHOL) AEROSOL, SPRAY [COSMETIC SPECIALTY LABS, INC.]6Legacy NDC, 1 package rows20210831_bf3eceb7-aed8-337b-e053-2995a90ace41.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-95958133-959-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
cac85b69-09cc-9492-e053-2995a90a8c8dbf3eceb7-aed8-337b-e053-2995a90ace412021-08-30WarningsExact identifier
spl id: cac85b69-09cc-9492-e053-2995a90a8c8d
spl set id: bf3eceb7-aed8-337b-e053-2995a90ace41

Reported adverse events (FAERS/openFDA)#

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