FDA.reportPublic FDA data

Saninta Hand Sanitizing Gel

Manufacturer
LL Pharma | LL Pharma Inc.
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:23:34

Label at a glance#

ProductSaninta Hand Sanitizing Gel
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Dosage and administration

Rub hands thoroughly for at least 30 seconds. Allow to dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15ºC - 30ºC (59º-86ºF) Avoid freezing and excessive heat above 40ºC (104ºF).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Antiseptic skin cleanser to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. For occasional and personal domestic use.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

Do not use

  • In children less than 2 months of age
  • On open skin wounds

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

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 at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rub hands thoroughly for at least 30 seconds. Allow to dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

  • Store between 15ºC - 30ºC (59º-86ºF)
  • Avoid freezing and excessive heat above 40ºC (104ºF).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aminomethylpropanol, Caprylyl glycol, Carbomer copolymer type B, Glycerin, Isopropyl myristate, Purified Water, Tocopherol acetate (Vitamin E)

Questions or Comments?

OTC - QUESTIONS SECTION

Questions or Comments? Tel.: 1-833-336-6159

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 81351-002-01

Product No.: 002-01

Saninta Hand Sanitizing Gel

70% v/v Isopropyl Alcohol USP

Effective for hand sanitizing

Kills harmful bacteria

Moisturizing with Vitamin E

Manufactured by:

LL Pharma Inc.

5789 rue Cypihot, Saint-Laurent (Montreal), Quebec H4S 1R3

Made in Canada

4 oz

www.llpharmainc.com

Do not use if security seal is broken.

Pull the safety seal to open.

Flip open the cap. Close the cap when done dispensing the product.

UPC Code

LOT #: XXXX

EXP.: MM/YYYY

F004 Rev. 1 FEB 2021

image of 81351-002-01 - 4 ozimage of 81351-002-01 - 4 oz

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81351-002SANINTA HAND SANITIZING GEL (ALCOHOL) LIQUID [LL PHARMA]3Legacy NDC20231022_bd9f1acd-d681-9d13-e053-2a95a90a5868.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81351-00281351-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
47446355-315e-6485-e063-6294a90a0377bd9f1acd-d681-9d13-e053-2a95a90a58682025-12-31WarningsExact identifier
spl set id: bd9f1acd-d681-9d13-e053-2a95a90a5868

Reported adverse events (FAERS/openFDA)#

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