Coastal Hand Sanitizer Gel

Manufacturer
U.S. BEVERAGE, INC.
Effective date
2020-08-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:23:44

Label at a glance#

ProductCoastal Hand Sanitizer Gel
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

Coasstal Hand Sanitizer Gel hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade active ingredient in the preparation of the product (percentage in final product formulation)

  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

Inactive Ingredients

  1. Glycerol (7.6% v/v).
  2. Isopropyl Alcohol ((0.3% v/v)
  3. Hydrogen peroxide (0.1% v/v).
  4. Carbomer (0.4%)
  5. Vitamin E (0.3% v/v)
  6. Sterile distilled water

Label Gallon Bottle with FDA Logo 1 gallon

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% 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, Isopropyl Alchol, Carbomer, Vitamin E, and purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 79076-900-41

Label Gallon Bottle with FDA Logo 1 gallon

Label Gallon Bottle with FDA Logo 1 One Gallon Bottle LabelOne Gallon Bottle Labelgallon Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79076-900-04Coastal Hand Sanitizer Gel118 mL in 1 BOTTLEGEL1182
79076-900-16Coastal Hand Sanitizer Gel473 mL in 1 BOTTLEGEL4732
79076-900-25Coastal Hand Sanitizer Gel9463 mL in 1 BAGGEL94632
79076-900-27Coastal Hand Sanitizer Gel1040988 mL in 1 CONTAINERGEL10409882
79076-900-32Coastal Hand Sanitizer Gel946 mL in 1 BOTTLEGEL9462
79076-900-41Coastal Hand Sanitizer Gel00 mL in 1 BOTTLEGEL002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79076-900COASTAL HAND SANITIZER GEL (HAND SANITIZER GEL) GEL [U.S. BEVERAGE, INC.]2Legacy NDC, 6 package rows20200805_a7d1791f-da40-e77c-e053-2995a90a8c76.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
79076-90079076-900-41, 79076-900-32, 79076-900-16, 79076-900-04, 79076-900-25, 79076-900-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
ac105972-73a4-dc47-e053-2995a90a6617a7d1791f-da40-e77c-e053-2995a90a8c762020-08-04WarningsExact identifier
spl id: ac105972-73a4-dc47-e053-2995a90a6617
spl set id: a7d1791f-da40-e77c-e053-2995a90a8c76

Reported adverse events (FAERS/openFDA)#

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