FDA.reportPublic FDA data

Stream2Sea Hand Sanitizer

Manufacturer
Stream2Sea, LLC
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:40:41

Label at a glance#

ProductStream2Sea Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Shake well before use. 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 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Part 333: Topical Antimicrobial Drug Products for Over The Counter Human Use.

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) (60+%, 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 (1.30% v/v).
  3. Deionized Water
  4. Eucalyptus Globulus Leaf Oil
  5. Camphor
  6. Mixed Tocopherols (Vitamine E)

The firm does not add other active ingredients.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% 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

  • Shake well before use.
  • 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 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Glycerin, Eucalyptus Globulus Leaf Oil, Camphor, Mixed Tocopherols (Vitamine E)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.3 fl. oz / 10 mL NDC: 69555-062-10

0.3 fl. oz / 10 mL NDC: 69555-062-100.3 fl. oz / 10 mL NDC: 69555-062-10

4 fl. oz / 120 mL NDC: 69555-062-04

4 fl. oz / 10 mL NDC: 69555-062-044 fl. oz / 10 mL NDC: 69555-062-04

128 fl. oz / 1 Gal. / 3785 mL NDC: 69555-062-12

128 fl. oz / 1 Gal. / 3785 mL NDC: 69555-062-12128 fl. oz / 1 Gal. / 3785 mL NDC: 69555-062-12

2 fl. oz / 60 mL NDC: 69555-062-02

NDC: 69555-062-02NDC: 69555-062-02

16 fl. oz / 473 mL NDC: 69555-062-16

NDC: 69555-062-16NDC: 69555-062-16

32 fl. oz / 946 mL NDC: 69555-062-32

NDC: 69555-062-32NDC: 69555-062-32

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69555-06269555-062-02, 69555-062-04, 69555-062-16, 69555-062-32, 69555-062-10, 69555-062-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
EUCALYPTUS OIL2R04ONI662IACT
CAMPHOR, (-)-213N3S8275IACT
ALCOHOL3K9958V90MACTIB

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
2ca28019-6dab-f90c-e063-6294a90a04ddce18f308-1772-4422-9b3d-c2aa7eeedfdb2025-01-26WarningsExact identifier
spl set id: ce18f308-1772-4422-9b3d-c2aa7eeedfdb

Reported adverse events (FAERS/openFDA)#

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