FDA.reportPublic FDA data

CDC70HS Hand Sanitizer

Manufacturer
Canadian Distribution Channel
Effective date
2020-08-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:24:16

Label at a glance#

ProductCDC70HS Hand Sanitizer
Active ingredientALCOHOL
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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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

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 CDC70HS 100ml, 500ml, 1890ml, 2L and 3,79L, 300 ml, 60 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label for 100ml 76984-442-01

769844301 100ml769844301 100ml

Label for 500ml 76984-442-02

500ml500ml

Label for 1.89L 76984-442-03

1.89L 76984-442-031.89L 76984-442-03

Label for 2L 76984-442-04

Label for 2L 76984-442-04Label for 2L 76984-442-04

Label for 3.79L 76984-442-05

Label for 3.79L 76984-442-05Label for 3.79L 76984-442-05

Label for CDC70HS 300 ml 76984-442-06

300 ml 76984-442-06300 ml 76984-442-06

Label for CDC70HS 60ml 76984-442-07

CDC70HS 60ml 76984-442-07CDC70HS 60ml 76984-442-07

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76984-442-012022-01-28C16284748780-1d6a99b39-9355-a426-e053-dadaa90af4c2CDC70HS Liquid 76984-442
76984-442-022022-01-28C16284748780-1d6a99b39-9355-a426-e053-dadaa90af4c2CDC70HS Liquid 76984-442
76984-442-032022-01-28C16284748780-1d6a99b39-9355-a426-e053-dadaa90af4c2CDC70HS Liquid 76984-442
76984-442-042022-01-28C16284748780-1d6a99b39-9355-a426-e053-dadaa90af4c2CDC70HS Liquid 76984-442
76984-442-052022-01-28C16284748780-1d6a99b39-9355-a426-e053-dadaa90af4c2CDC70HS Liquid 76984-442
76984-442-062022-01-28C16284748780-1d6a99b39-9355-a426-e053-dadaa90af4c2CDC70HS Liquid 76984-442
76984-442-072022-01-28C16284748780-1d6a99b39-9355-a426-e053-dadaa90af4c2CDC70HS Liquid 76984-442

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76984-442-01CDC70HS Hand Sanitizer100 mL in 1 BOTTLE, PLASTICLIQUID1003
76984-442-02CDC70HS Hand Sanitizer500 mL in 1 BOTTLE, PLASTICLIQUID5003
76984-442-03CDC70HS Hand Sanitizer1890 mL in 1 BOTTLE, PLASTICLIQUID18903
76984-442-04CDC70HS Hand Sanitizer2000 mL in 1 BOTTLE, PLASTICLIQUID20003
76984-442-05CDC70HS Hand Sanitizer3790 mL in 1 BOTTLE, PLASTICLIQUID37903
76984-442-06CDC70HS Hand Sanitizer300 mL in 1 BOTTLE, PLASTICLIQUID3003
76984-442-07CDC70HS Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76984-442CDC70HS HAND SANITIZER (ETHANOL) LIQUID [CANADIAN DISTRIBUTION CHANNEL]3Legacy NDC, 7 package rows20200811_a40e27a1-61cb-7e7d-e053-2a95a90a5914.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76984-44276984-442-01, 76984-442-02, 76984-442-03, 76984-442-04, 76984-442-05, 76984-442-06, 76984-442-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT

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
ac905e3a-8a04-4bcc-e053-2a95a90a107da40e27a1-61cb-7e7d-e053-2a95a90a59142020-08-10WarningsExact identifier
spl id: ac905e3a-8a04-4bcc-e053-2a95a90a107d
spl set id: a40e27a1-61cb-7e7d-e053-2a95a90a5914

Reported adverse events (FAERS/openFDA)#

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