Hand Sanitizer

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2023-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:52

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 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. updated effective date to 05/03/2023

Storage and handling

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

Label contents#

Full prescribing information#

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.

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

updated effective date to 05/03/2023

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 sprayer NDC: 58133-959-2015 mL sprayer NDC: 58133-959-2015 mL sprayer NDC: 58133-961-2015 mL sprayer NDC: 58133-961-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286295ethanol 75 % Topical SprayPSN1
2286295ethanol 0.75 ML/ML Topical SpraySCD1
2286295ethanol 75 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-959-202024-07-30C16284748780-11e7a6dab-1943-a2ce-e063-dadaa90aadf7facff016-83f6-5b4f-e053-6294a90af0fa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-959-20Hand Sanitizer15 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-959HAND SANITIZER (ALCOHOL) AEROSOL, SPRAY [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 1 package rows20230504_facff016-83f6-5b4f-e053-6294a90af0fa.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
58133-95958133-959-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
facff02c-29bf-95ce-e053-6294a90a5132facff016-83f6-5b4f-e053-6294a90af0fa2023-05-03WarningsExact identifier
spl id: facff02c-29bf-95ce-e053-6294a90a5132
spl set id: facff016-83f6-5b4f-e053-6294a90af0fa

Reported adverse events (FAERS/openFDA)#

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