FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Botanicala LLC | Botanicala, LLC
Effective date
2020-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:34

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product in your palm to thoroughly cover your hands and rub hands together until dry (about 20 seconds) Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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 Center for Disease Control (CDC) recommendations:

  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 (2% v/v).
  3. Carbomer 980 (0.2% v/v).
  4. Sodium Hydroxide (<0.02% v/v).
  5. Sterile ultrapure 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 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Hand Sanitizer to help reduce bacteria on the skin

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from source of heat, fire, or flame. For external use only.

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops 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 Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands and rub hands together until dry (about 20 seconds)
  • Children under 6 years of age should be supervised when using this product.

Other information

OTHER SAFETY INFORMATION

  • Store at a temperature below 105F (40C)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, C70-100 Carbomer, Sodium Hydroxide

POSTMARKETING EXPERIENCE SECTION

Questions or comments? 1-800-535-4980

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55 mL NDC: 99907-603-01

Principal Drug Facts Label PanelPrincipal Drug Facts Label PanelFront PanelFront PanelBack PanelBack Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77709-603-012022-01-28C16284748780-1d6a99b39-7269-a426-e053-dadaa90af4c2Botanicala 70% Ethyl Alcohol Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77709-603-01Hand Sanitizer55 mL in 1 BOTTLE, DISPENSINGGEL551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77709-603HAND SANITIZER GEL [BOTANICALA LLC]1Legacy NDC, 1 package rows20200519_a503f47d-3456-2a17-e053-2995a90a4ef2.zip

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
77709-60377709-603-01

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
GLYCERINPDC6A3C0OXIACT
CARBOMER 9804Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML · Source PDF

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
a503f4a1-3616-b347-e053-2a95a90a11baa503f47d-3456-2a17-e053-2995a90a4ef22020-05-06WarningsExact identifier
spl id: a503f4a1-3616-b347-e053-2a95a90a11ba
spl set id: a503f47d-3456-2a17-e053-2995a90a4ef2

Reported adverse events (FAERS/openFDA)#

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