79195-005 1000ml Fist Step By Enchant

79195-005 1000ml Fist Step By Enchant
SPL v1
SPL
SPL Set ID a9be67aa-b0ab-5fe7-e053-2a95a90add7a
Route
EXTRACORPOREAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (680 mL)
Inactive Ingredients
Fragrance Lavender & Chia F-153480 Hyaluronate Sodium Aminomethylpropanol Water Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

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.


Medication Information

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.

Description

Alcohol 68% v/v. Purpose: Antiseptic

Use

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

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.

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.

Directions
  • Wet hands with product and rub briskly until dry./Direcciones Humedezca las monos con el producto y frotelas energicamnte hasta que se seque.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
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.
Active Ingredient(s)

Alcohol 68% v/v. Purpose: Antiseptic

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

1000 ml in 1 bottle NDC: 79195-005-01


Structured Label Content

Use

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

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.

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.

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.

Directions
  • Wet hands with product and rub briskly until dry./Direcciones Humedezca las monos con el producto y frotelas energicamnte hasta que se seque.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (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.
Active Ingredient(s)

Alcohol 68% v/v. Purpose: Antiseptic

Inactive Ingredients (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 (Package Label - Principal Display Panel)

1000 ml in 1 bottle NDC: 79195-005-01


Advanced Ingredient Data


Raw Label Data

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