Siles Hand Sanitizer Gel by SILES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE COSMETICOS LTDA

Drug Details [pdf]

SILES HAND SANITIZER GEL- alcohol 70% gel
SILES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE COSMETICOS LTDA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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This is a hand sanitizer manufactured using only the following :

Alcohol (ethanol) (70%, volume/volume (v/v))
Water
Propylene Glycol
Trolamine
Fragrance Lemon Orc2001060
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)
Methylchloroisothiazolinone
Methylisothiazolinone
Triclosan
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)

Alcohol 70% v/v.

Purpose

Antiseptic, Hand Sanitizer

Use

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

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

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

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

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

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

Inactive ingredients

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

Package Label - Principal Display Panel

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

Siles Hand Sanitizer 500mL

SILES HAND SANITIZER GEL
alcohol 70% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80440-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
TRICLOSAN (UNII: 4NM5039Y5X)
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 80440-101-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/15/2021	12/31/2021

Labeler - SILES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE COSMETICOS LTDA (898265515)

Registrant - SILES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE COSMETICOS LTDA (898265515)

Name	Address	ID/FEI	Business Operations
Establishment
SILES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE COSMETICOS LTDA		898265515	manufacture(80440-101)

Revised: 4/2022

Document Id: db9ec6d0-af59-971d-e053-2995a90a37fe

Set id: b4f70841-7984-847b-e053-2995a90ac11e

Version: 3

Effective Time: 20220401

SILES INDUSTRIA COMERCIO IM