sani luxe ®

sani luxe ®
SPL v13
SPL
SPL Set ID 1a259dcf-4d82-4a42-be1f-0e557e0940bd
Route
cutaneous
Published
Effective Date 2020-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.625 mL)
Inactive Ingredients
water peg-4 diheptanoate carbomer copolymer type a (allyl pentaerythritol crosslinked) aminomethylpropanol hydroxypropyl cellulose, unspecified

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-01-24

Purpose

Antimicrobial

Description

Drug Facts


Medication Information

Warnings
  • For external use only.
  • Flammable. Keep away from open flame and sources of heat.
Uses
  • Recommended for repeated use
  • For hand sanitizing to decrease bacteria on the skin
Purpose

Antimicrobial

Directions
  • Children under 6 years of age should be supervised when using this product
  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
Other Information
  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients

Aqua, PEG-4 Diheptanoate, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Fragrance, Aminomethyl Propanol

May contain hydroxypropylcellulose.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children.
Section 50566-9
  • Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
Section 50567-7
  • When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.
  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 51945-4

Sani Luxe ®



HAND SANITIZER GEL



with Alcohol

  • Requires no water or towels.
  • Apply small amount to hands



    and rub until dry.

Kills 99%



of germs



on contact

Caution: Use on hands only.

284ml e

Active Ingredient

Ethyl Alcohol 62.5%


Structured Label Content

Warnings
  • For external use only.
  • Flammable. Keep away from open flame and sources of heat.
Uses
  • Recommended for repeated use
  • For hand sanitizing to decrease bacteria on the skin
Purpose

Antimicrobial

Directions
  • Children under 6 years of age should be supervised when using this product
  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
Other Information (Other information)
  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

Aqua, PEG-4 Diheptanoate, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Fragrance, Aminomethyl Propanol

May contain hydroxypropylcellulose.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
Section 50567-7 (50567-7)
  • When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.
  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 51945-4 (51945-4)

Sani Luxe ®



HAND SANITIZER GEL



with Alcohol

  • Requires no water or towels.
  • Apply small amount to hands



    and rub until dry.

Kills 99%



of germs



on contact

Caution: Use on hands only.

284ml e

Active Ingredient (Active ingredient)

Ethyl Alcohol 62.5%


Advanced Ingredient Data


Raw Label Data

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