Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Instant Hand Sanitizer
FDA Label NDC 79195-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by First Step Safety Products Corporation for the product Instant Hand Sanitizer (NDC 79195-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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.
Otc - Stop Use
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
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,CARBOMER COPOLYMER TYPE A,CARBOMER COPOLYMER TYPE A,CARBOMER COPOLYMER TYPE A,LEMON
Package Label - Principal Display Panel
1 Gallon in 1 bottle NDC: 79195-012-01
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