LINSTOL REFRESHING AND CLEANSING HAND SANITIZER- alcohol gel 
Linstol USA, LLC

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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Linstol Refreshing & Cleaning Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only

Flammable. Keep away from fire or flame.

When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use or ask a doctor if irritation or rash appears and lasts.

  • You may report side effects to FDA at 1-800-FDA-1088.

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

Directions

Inactive ingredients

Water (Aqua), Carbomer, Fragrance, Glycerin, Racementhol, Trolamine.

Distributed by: Linstol USA, LLC
Naples, FL 34114

PRINCIPAL DISPLAY PANEL - 2 ml Packet

REFRESHING & CLEANSING

HAND
SANITISER

Contains 75% Alcohol

2ml / 0.07 fl. oz.
PARABEN & TRICLOSAN FREE

PRINCIPAL DISPLAY PANEL - 2 ml Packet
LINSTOL REFRESHING AND CLEANSING HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76982-3864
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
RACEMENTHOL (UNII: YS08XHA860)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76982-3864-02 mL in 1 PACKET; Type 0: Not a Combination Product05/20/2020
2NDC:76982-3864-115 mL in 1 TUBE; Type 0: Not a Combination Product05/20/2020
3NDC:76982-3864-230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
4NDC:76982-3864-359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
5NDC:76982-3864-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
6NDC:76982-3864-5236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2020
7NDC:76982-3864-6500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2020
8NDC:76982-3864-7532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2020
Labeler - Linstol USA, LLC (828039995)

Revised: 12/2022
Document Id: f0591141-fb32-00a4-e053-2a95a90aab87
Set id: 71dd1b18-c573-44c6-b544-3ad4d437a2ef
Version: 5
Effective Time: 20221221
 
Linstol USA, LLC