Hand Sanitizer

Manufacturer
Andes Ingredients LLC
Effective date
2020-06-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:36

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v)..
  3. Sterile distilled water or boiled cold water.

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

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785.42 mL NDC: 77832-100-01

The back of the 1 g 77832-100-01The back of the 1 g 77832-100-01

3785.42 mL NDC: 77832-100-01

The front of 1 gallon. 77832-100-01The front of 1 gallon. 77832-100-01

204412 mL NDC: 77832-101-54

for 77832-101- 54gallonsfor 77832-101- 54gallons

59.15 mL NDC: 77832-101-02

This is for 77832-101 2ozThis is for 77832-101 2oz

208197 mL NDC: 77832-100-55

55g drum (208197 mL)55g drum (208197 mL)946352 mL NDC: 77832-100-25

250g tote/tank (946352 mL)250g tote/tank (946352 mL)354 ml NDC: 77832-100-12

This si for the 12oz bottleThis si for the 12oz bottle473 ml NDC: 77832-100-16 16oz label16oz label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN2
2285607isopropyl alcohol 75 % Topical GelPSN2
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD2
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD2
581698isopropyl alcohol 70 % Topical GelSY2
2285607isopropyl alcohol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77832-100-01Hand Sanitizer3785.42 mL in 1 BOTTLE, PLASTICGEL3785.422
77832-100-12Hand Sanitizer350 mL in 1 BOTTLE, PLASTICGEL3502
77832-100-16Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4732
77832-100-25Hand Sanitizer946352 mL in 1 TANKGEL9463522
77832-100-55Hand Sanitizer208197 mL in 1 DRUMGEL2081972
77832-101-02Hand Sanitizer59.15 mL in 1 BOTTLE, PLASTICGEL59.152
77832-101-54Hand Sanitizer204412 mL in 1 DRUMGEL2044122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77832-100HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [ANDES INGREDIENTS LLC]2Legacy NDC, 5 package rows20200623_a5652d5b-8513-5c89-e053-2995a90aea29.zip
77832-101HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [ANDES INGREDIENTS LLC]2Legacy NDC, 2 package rows20200623_a5652d5b-8513-5c89-e053-2995a90aea29.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
a875308c-01ee-bad8-e053-2995a90aafe6a5652d5b-8513-5c89-e053-2995a90aea292020-06-19WarningsExact identifier
spl id: a875308c-01ee-bad8-e053-2995a90aafe6
spl set id: a5652d5b-8513-5c89-e053-2995a90aea29

Reported adverse events (FAERS/openFDA)#

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