FDA.reportPublic FDA data

Pro-Sanitize Advanced with Aloe Vera

Manufacturer
Clean Beauty Concepts
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:07

Label at a glance#

ProductPro-Sanitize Advanced with Aloe Vera
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water. (27.465%)
  5. Acrylates/C10 30 Alkyl acrylate crosspolymer(.20% v/v)
  6. Aminomethyl propanol (.06% v/v)
  7. Fragrance (Parfum) (.3% v/v)
  8. Aloe vera lead extract (0.4%)

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water(aqua), glycerin, acrylates/C10 30 alkyl acrylate crosspolymer, aminomethyl propanol, hydrogen peroxide, fragrance(parfum), Aloe Barbadensis

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473 mL NDC: 76665-004-16

473 ml473 ml

60 mL NDC: 76665-004-02

60ml60ml

236 mL NDC: 76665-004-08

236ml236ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76665-004-022022-01-28C16284748780-1d6a99b39-aa5f-a426-e053-dadaa90af4c2a8e8d162-d717-6bb5-e053-2995a90afcb6
76665-004-082022-01-28C16284748780-1d6a99b39-aa5f-a426-e053-dadaa90af4c2a8e8d162-d717-6bb5-e053-2995a90afcb6
76665-004-162022-01-28C16284748780-1d6a99b39-aa5f-a426-e053-dadaa90af4c2a8e8d162-d717-6bb5-e053-2995a90afcb6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76665-004-02Pro-Sanitize Advanced with Aloe Vera60 mL in 1 BOTTLE, DISPENSINGLIQUID601
76665-004-08Pro-Sanitize Advanced with Aloe Vera236 mL in 1 BOTTLE, DISPENSINGLIQUID2361
76665-004-16Pro-Sanitize Advanced with Aloe Vera473 mL in 1 BOTTLE, DISPENSINGLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76665-004PRO-SANITIZE ADVANCED WITH ALOE VERA (HAND SANITIZER) LIQUID [CLEAN BEAUTY CONCEPTS]1Legacy NDC, 3 package rows20200626_a8e8d162-d717-6bb5-e053-2995a90afcb6.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76665-00476665-004-16, 76665-004-02, 76665-004-08

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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
a8e8da7f-d669-a5c4-e053-2a95a90ad5c4a8e8d162-d717-6bb5-e053-2995a90afcb62020-06-25WarningsExact identifier
spl id: a8e8da7f-d669-a5c4-e053-2a95a90ad5c4
spl set id: a8e8d162-d717-6bb5-e053-2995a90afcb6

Reported adverse events (FAERS/openFDA)#

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