STEAM2SEA ESSENTIAL HAND SANITIZER GEL- alcohol gel

Steam2Sea Essential Hand Sanitizer Gel by

Drug Labeling and Warnings

Steam2Sea Essential Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)
7. Hydroxypropyl Guar (1% v/v)
8. Citric Acid (less than 0.5% v/v)

The firm does not add other active ingredients.

Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Deionized Water, Glycerin, Eucalyptus Globulus Leaf Oil, Camphor, Mixed Tocopherols (Vitamine E), Hydroxypropyl Guar, Citric Acid

Package Label - Principal Display Panel

2 fl. oz / 60 mL NDC: 69555-062-01

4 fl. oz / 118 mL NDC: 69555-062-04

INGREDIENTS AND APPEARANCE

STEAM2SEA ESSENTIAL HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69555-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CAMPHOR, (-)- (UNII: 213N3S8275)
GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69555-063-01	1 in 1 BOX	05/12/2020
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69555-063-04	1 in 1 BOX	05/12/2020
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/12/2020

Labeler - Stream2Sea, LLC (052920828)

Registrant - Stream2Sea, LLC (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(69555-063)