HAND SANITIZER GEL- ethyl alcohol gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Guide Energy Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient[s]:

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

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 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.

Directions

• 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 (59-83°F)
• Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive Ingredients glycerin, hydrogen peroxide, monoethanolamine, acrylate copolymer, fragrance, water

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80% Gel

Non-sterile Solution

Signal Word: Danger

Proper Shipping Name: Ethanol solution

UN1170

Hazard Class 3

Packing Group II

FLAMMABLE LIQUID 3

HAZARD STATEMENTS:
H225 - Highly flammable liquid and vapor.
H319 - Causes serious eye irritation.
H336 – May cause drowsiness or dizziness

PRECAUTION STATEMENTS:
P210 - Keep away from heat/sparks/open flames/hot surfaces. No smoking.
P233 - Keep container tightly closed.
P240 - Ground and bond container and receiving equipment
P241+P242 - Use explosion-proof electrical, ventilating and lighting equipment. Use only non-sparking tools.
P243 - Take precautionary measures against static discharge.
P261 - Avoid breathing fumes, mist and vapor.
P264 - Wash hands and other exposed skin areas thoroughly after handling.
P271 - Use only outdoors or in a well-ventilated area.
P280 - Wear protective gloves/protective clothing/eye protection/face protection.
P303+P361+P353 - IF ON SKIN (or hair): Remove immediately all contaminated clothing. Rinse skin with water or shower.
P304+P340+P312 - IF INHALED: Remove victim to fresh air and keep at rest in a comfortable position for breathing. Call a POISON CENTER or doctor if you feel unwell.
P305+P351+P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P370+P378 - In case of fire: Use water fog, foam, dry chemical or carbon dioxide for extinction.
P405+P403+P233+P235 - Store locked up in a well-ventilated place. Keep container tightly closed. Keep cool.
P501 - Dispose of contents/container to authorized hazardous or special waste collection point in accordance with any local regulation.

Guide Energy Solutions, LLC  9330 South Hwy 99  Prague, OK 74864

For Chemical Emergencies: Call Chemtrec at (800) 424-9300. See SDS (Safety Data Sheet) for further information.

Packaging

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77042-780
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
MONOETHANOLAMINE (UNII: 5KV86114PT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77042-780-01	3.785 L in 1 JUG; Type 0: Not a Combination Product	05/13/2020
2	NDC: 77042-780-32	0.946 L in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2020
3	NDC: 77042-780-12	0.3548 L in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2020
4	NDC: 77042-780-08	0.237 L in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/13/2020

Labeler - Guide Energy Solutions LLC (117045830)