SMPLY Aloe Hand Sanitizer

Manufacturer
Froggy's Fog LLC
Effective date
2021-03-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:44

Label at a glance#

ProductSMPLY Aloe Hand Sanitizer
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

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) (80%, 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.

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(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, 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.

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

glycerin, hydrogen peroxide, purified water USP

SMPLY Aloe Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMPLY Sanitizer CitrusSMPLY Sanitizer Citrus1893mL NDC: 75682-775-64 SMPLY Sanitizer CitrusSMPLY Sanitizer Citrus208198mL NDC: 75682-775-55 SMPLY Sanitizer CitrusSMPLY Sanitizer Citrus946353mL NDC: 75682-775-25 SMPLY Aloe Hand SanitizerSMPLY Aloe Hand Sanitizer236 mL NDC: 75682-775-08 SMPLY Aloe Hand SanitizerSMPLY Aloe Hand Sanitizer118 mL NDC: 75682-775-04 SMPLY Aloe Hand SanitizerSMPLY Aloe Hand Sanitizer946 mL NDC: 75682-775-32 SMPLY Aloe Hand SanitizerSMPLY Aloe Hand Sanitizer59 mL NDC: 75682-775-02 SMPLY Aloe Hand SanitizerSMPLY Aloe Hand Sanitizer473 mL NDC: 75682-775-16 SMPLY Aloe Hand SanitizerSMPLY Aloe Hand Sanitizer3785 mL NDC: 75682-775-01

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75682-775-01SMPLY Aloe Hand Sanitizer3785 mL in 1 JUGGEL37852
75682-775-02SMPLY Aloe Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL592
75682-775-04SMPLY Aloe Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1182
75682-775-08SMPLY Aloe Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2362
75682-775-16SMPLY Aloe Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4732
75682-775-25SMPLY Aloe Hand Sanitizer946353 mL in 1 TANKGEL9463532
75682-775-32SMPLY Aloe Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9462
75682-775-55SMPLY Aloe Hand Sanitizer208198 mL in 1 DRUMGEL2081982
75682-775-64SMPLY Aloe Hand Sanitizer1893 mL in 1 JUGGEL18932

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75682-775SMPLY ALOE HAND SANITIZER (ALCOHOL) GEL [FROGGY'S FOG LLC]2Legacy NDC, 9 package rows20210305_b816046d-d448-5ba9-e053-2a95a90ace48.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
bcb9180f-1404-7b27-e053-2995a90a95a4b816046d-d448-5ba9-e053-2a95a90ace482021-03-04WarningsExact identifier
spl id: bcb9180f-1404-7b27-e053-2995a90a95a4
spl set id: b816046d-d448-5ba9-e053-2a95a90ace48

Reported adverse events (FAERS/openFDA)#

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