Siles Hand Sanitizer Gel

Manufacturer
SILES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE COSMETICOS LTDA
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:12:53

Label at a glance#

ProductSiles Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Apply the desired amount to the palm of your hand and rub until completely dry without wiping supervise children in the use of this product use only as directed

Storage and handling

Store between 59-86°F Keep sealed between uses Avoid freezing and heat above 104ºF May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured using only the following :

  1. Alcohol (ethanol) (70%, volume/volume (v/v))
  2. Water
  3. Propylene Glycol
  4. Trolamine
  5. Fragrance Lemon Orc2001060
  6. Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)
  7. Methylchloroisothiazolinone
  8. Methylisothiazolinone
  9. Triclosan
  10. Denatonium Benzoate

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

  • To decrease bacteria on the skin that could cause disease
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes, ears, and mouth
  • If contact occurs with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • avoid inhalation
  • if inhaled for prolonged period, seek immediate medical attention

OTC - STOP USE SECTION

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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply the desired amount to the palm of your hand and rub until completely dry without wiping
  • supervise children in the use of this product
  • use only as directed

Other information

STORAGE AND HANDLING SECTION

  • Store between 59-86°F
  • Keep sealed between uses
  • Avoid freezing and heat above 104ºF
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Trolamine, Fragrance Lemon Orc2001060, Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked), Methylchloroisothiazolinone, Methylisothiazolinone, Triclosan, Denatonium Benzoate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16.90 fl oz (500 mL) NDC: 80440-101-01

Siles Hand Sanitizer 500mLSiles Hand Sanitizer 500mL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80440-10180440-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
db9ec6d0-af59-971d-e053-2995a90a37feb4f70841-7984-847b-e053-2995a90ac11e2022-04-01WarningsExact identifier
spl set id: b4f70841-7984-847b-e053-2995a90ac11e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.