FDA.reportPublic FDA data

Cottonwood Sanitizer

Manufacturer
Alpine Distilling
Effective date
2020-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:15

Label at a glance#

ProductCottonwood Sanitizer Gel
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Apply to dry hands, rub into skin, no rinsing required.

Label contents#

Full prescribing information#

Active Ingredient(s):

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% v/v

Purpose :

OTC - PURPOSE SECTION

Antibacterial

Use(s):

INDICATIONS & USAGE SECTION

For rinse free hand cleaning when soap and water are not available.

Warning:

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product: Avoid contact with eyes, ears and mouth. In case of eye contact, rinse with water. 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 & pets. If swallowed, get medical help or contact a Poison Control Center Right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply to dry hands, rub into skin, no rinsing required.

Other Information:

OTHER SAFETY INFORMATION

Store between 15-30C (59-86F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Glycerin, Betaine, Polyacrylamide, Isoparaffin, Laureth-7, Purified Water USP, Fragrance

Manufactured by Cottonwood Spirits LLC – 7132 N Silver Creek Road, Park City Utah 84098

DUNS: 080985574 FDA/NDC: 78002

435-200-9537 info@alpinedistilling.com

Principal Display Panel – 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COTTONWOORD
HAND SANITIZER
WITH ESSENTIAL OILS

UNSCENTED

16 OZ – 500 mL

Principal Display Panel – 500 mL Bottle Label
Principal Display Panel – 500 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78002-101-012022-01-28C16284748780-1d6a99b39-5c77-a426-e053-dadaa90af4c2Drug Facts
78002-101-022022-01-28C16284748780-1d6a99b39-5c77-a426-e053-dadaa90af4c2Drug Facts
78002-101-032022-01-28C16284748780-1d6a99b39-5c77-a426-e053-dadaa90af4c2Drug Facts
78002-101-042022-01-28C16284748780-1d6a99b39-5c77-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78002-101-01Cottonwood Sanitizer Gel50 mL in 1 BOTTLEGEL501
78002-101-02Cottonwood Sanitizer Gel100 mL in 1 BOTTLEGEL1001
78002-101-03Cottonwood Sanitizer Gel250 mL in 1 BOTTLEGEL2501
78002-101-04Cottonwood Sanitizer Gel500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78002-101COTTONWOOD SANITIZER GEL (ALCOHOL) GEL [ALPINE DISTILLING]1Legacy NDC, 4 package rows20200714_e964e970-bd09-4398-861a-3123372886ab.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78002-10178002-101-01, 78002-101-02, 78002-101-03, 78002-101-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GlycerinPDC6A3C0OXIACT
Betaine3SCV180C9WIACT
Polyacrylamide (Crosslinked; 0.01-0.2 Mole Percent Bisacrylamide)RHA9LWJ494IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
Laureth-7Z95S6G8201IACT
Water059QF0KO0RIACT

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
6c40fff4-70b8-4016-aeaf-cb5aa2fff6d3e964e970-bd09-4398-861a-3123372886ab2020-07-06WarningsExact identifier
spl id: 6c40fff4-70b8-4016-aeaf-cb5aa2fff6d3
spl set id: e964e970-bd09-4398-861a-3123372886ab

Reported adverse events (FAERS/openFDA)#

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