INSTANT HAND SANITIZER gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by First Step Safety Products Corporation, Zhejiang Enchant Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 68% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use for handwashing to decrease bacteria on the skin./Uso para el lavado de monos y disminucion de las bacterias en la piel.

Use

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

Warnings

• Flammable,keep away from fire or flame.For external use only/Advertencias inflamables,conservese lejos fuego o llama.Para uso extreno solo.
• When using this product for external use on hands only.In case of contact with eyes,rinse with water/Usando este producto Para uso externo solamente.En caso del contacto on ojas ,aclare con el echar agaua.
• Stop use and ask a doctor If irritation and redness develops or presists.Inerrumpa el uso y consulte con un medico En caso de desarrollar irritacion y enrojecimiento,o de que estos sintomas persistan.
• Keep out of the reach of children. In case of accidental ingestion,seek professional assistance or contact a Poison Control Center immediately/Quedese fuera de alance de ninos.En caso de ingestion accidental,buscar ayuda profesional o ponerse en contacto con un Centro de Envenenamiento inmediatamente.

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

• Wet hands with product and rub briskly until dry./Direcciones Humedezca las monos con el producto y frotelas energicamnte hasta que se seque.

Other information

• Do not store above 100 F.May discolor some fabrics.Harmful to wood finishes and plastics./Mas Informacion No guardar a temperatura superior a 40 C.Padria destenir algunas telas.Perjudicial para acabados de madera y plasticos.

Inactive ingredients

WATER,BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW),AMINOMETHYLPROPANOL,ALOE VERA LEAF,HYALURONATE SODIUM,FRAGRANCE LAVENDER & CHIA F-153480

Package Label - Principal Display Panel

60 ml in 1 bottle NDC: 79195-006-01

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79195-006
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	40.8 mL  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79195-006-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - First Step Safety Products Corporation (117554463)

Registrant - Zhejiang Enchant Cosmetic Co., Ltd. (527284802)

Establishment
Name	Address	ID/FEI	Business Operations
First Step Safety Products Corporation		117554463	label(79195-006)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Enchant Cosmetic Co., Ltd.		527284802	manufacture(79195-006)