FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SECCO HCSP GROUP JSC
Effective date
2020-10-11
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:35:03

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Apply enough sanitizer into your palm Rub hands together, palm to palm Keep rubbing for 20 seconds Rub hands until dry P

Storage and handling

Store below 110F (43C)

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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. Hydrogen peroxide (0.125% v/v).
  4. 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

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin recommended for repeated use

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in the eyes. In case of contact rinse eyes thoroughly with water.
  • Keep out of reach of children. If swallowed, get medical help and contact a Poison Control Center right away.
  • Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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 and redness develop and persist for more than 72 hours.

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

  • Apply enough sanitizer into your palm
  • Rub hands together, palm to palm
  • Keep rubbing for 20 seconds
  • Rub hands until dry
  • P

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

distilled water, glycerine, carbomer 940, tween 20, azadirachtae indicae oil, aloe vera, essential oil, basil oil, rosemary, vitamin e.

RECENT MAJOR CHANGES SECTION

Indications and Usage: for handwashing to decrease bacteria on the skin recommended for repeated use (03-2020)

Dosage and administration: apply enough sanitizer into your palm, rub hands together plam to plam, keep rubbing for 20 seconds, rub hands until dry (03-2020)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml NDC: 76699-100-03

76699-100-0376699-100-03

76699-100-03-376699-100-03-3

50mL NDC: 76699-100-04

76699-100-0476699-100-04

76699-100-04-376699-100-04-3

60mL NDC: 76699-100-09

76699-100-09-376699-100-09-3

76699-100-09-276699-100-09-2

100 mL NDC: 76699-100-01

7669-100-01-47669-100-01-4

76699-100-01-276699-100-01-2

300 mL NDC: 76699-100-02

76699-100-0276699-100-02

76699-100-02-276699-100-02-2

500 mL NDC: 76699-100-05

76699-100-0576699-100-05

76699-100-05-376699-100-05-3

1000 mL NDC: 76699-100-06

76699-100-0676699-100-06

76699-100-06-376699-100-06-3

3.85L NDC: 76699-100-07

76699-100-07-276699-100-07-2

76699-100-0776699-100-07

208L NDC: 76699-100-08

76699-100-0876699-100-08

76699-100-08-376699-100-08-3

60mL: NDC 76699-100-09

76699-100-0976699-100-09

76699-100-09-376699-100-09-3

250mL: NDC 76699-100-10

76699-100-1076699-100-10

1.5mL: NDC 76699-100-13

76699-100-13-376699-100-13-3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN9
582753ethanol 0.7 ML/ML Topical SolutionSCD9
582753ethanol 70 % Topical SolutionSY9
582753ethyl alcohol 70 % Topical SolutionSY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76699-100-012022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-022022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-032022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-042022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-052022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-062022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-072022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-082022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-092022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-102022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-112022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58
76699-100-132022-01-28C16284748780-1d6a99b39-ce93-a426-e053-dadaa90af4c2a417de3f-4797-156f-e053-2995a90a4a58

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76699-100-01Hand Sanitizer100 mL in 1 BOTTLELIQUID1009
76699-100-02Hand Sanitizer300 mL in 1 BOTTLE, PUMPLIQUID3009
76699-100-03Hand Sanitizer30 mL in 1 BOTTLELIQUID309
76699-100-04Hand Sanitizer50 mL in 1 BOTTLELIQUID509
76699-100-05Hand Sanitizer500 mL in 1 BOTTLE, PUMPLIQUID5009
76699-100-06Hand Sanitizer1000 mL in 1 BOTTLE, PUMPLIQUID10009
76699-100-07Hand Sanitizer3850 mL in 1 BOTTLE, PUMPLIQUID38509
76699-100-08Hand Sanitizer208000 mL in 1 BOTTLE, PUMPLIQUID2080009
76699-100-09Hand Sanitizer60 mL in 1 BOTTLELIQUID609
76699-100-10Hand Sanitizer250 mL in 1 BOTTLELIQUID2509
76699-100-11Hand Sanitizer5000 mL in 1 BOTTLE, PUMPLIQUID50009
76699-100-13Hand Sanitizer1.5 mL in 1 BOTTLE, PUMPLIQUID1.59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76699-100HAND SANITIZER (ALCOHOL) LIQUID [SECCO HCSP GROUP JSC]9Legacy NDC, 12 package rows20201212_a417de3f-4797-156f-e053-2995a90a4a58.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76699-10076699-100-05, 76699-100-02, 76699-100-01, 76699-100-06, 76699-100-08, 76699-100-07, 76699-100-03, 76699-100-04, 76699-100-09, 76699-100-10, 76699-100-11, 76699-100-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CAJUPUT OILJ3TO6BUQ37IACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
ROSEMARYIJ67X351P9IACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BASIL OILZ129UMU8LEIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9404Q93RCW27EIACT

Source Document#

Source XML · Source PDF

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
b171f2ea-0dc5-2d13-e053-2995a90aa5a4a417de3f-4797-156f-e053-2995a90a4a582020-10-11WarningsExact identifier
spl id: b171f2ea-0dc5-2d13-e053-2995a90aa5a4
spl set id: a417de3f-4797-156f-e053-2995a90a4a58

Reported adverse events (FAERS/openFDA)#

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