FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Camden Passage Inc. | Rook Quality Systems
Effective date
2020-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:13:15

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL, ISOPROPYL 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. 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 80% 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

70jug.jpg is the 5L 70% alcohol-based sanitizer NDC: 77385-033-76

NDC 77385-033-76NDC 77385-033-76

70pump.jpg is the 500mL 70% alcohol-based sanitizer NDC: 77385-034-13

NDC: 77385-034-13NDC: 77385-034-13

80jug.jpg is the 5L 80% alcohol-based sanitizer NDC: 77385-057-38

NDC: 77385-057-38NDC: 77385-057-38

80pump.jpg is the 500 mL 80% alcohol-based sanitizer NDC: 77385-057-52

NDC: 77385-057-52NDC: 77385-057-52

5L Antiseptic Disinfectant_v01.jpg is the 5L 70% alcohol-based sanitizer NDC 77385-028-05

NDC 77385-028-05NDC 77385-028-05

500mL Antiseptic Disinfectant_v01.jpg is the 500mL 70% alcohol-based sanitizer spray NDC 77385-028-29

NDC 77385-028-29NDC 77385-028-29

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
1041498ethanol 80 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
1041498ethanol 0.8 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
1041498ethanol 80 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

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
77385-028-052022-01-28C16284748780-1d6a99b39-da07-a426-e053-dadaa90af4c2Ocean Free - Hand Sanitizer
77385-028-292022-01-28C16284748780-1d6a99b39-da07-a426-e053-dadaa90af4c2Ocean Free - Hand Sanitizer
77385-033-762022-01-28C16284748780-1d6a99b39-da07-a426-e053-dadaa90af4c2Ocean Free - Hand Sanitizer
77385-034-132022-01-28C16284748780-1d6a99b39-da07-a426-e053-dadaa90af4c2Ocean Free - Hand Sanitizer
77385-057-382022-01-28C16284748780-1d6a99b39-da07-a426-e053-dadaa90af4c2Ocean Free - Hand Sanitizer
77385-057-522022-01-28C16284748780-1d6a99b39-da07-a426-e053-dadaa90af4c2Ocean Free - Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77385-028-05hand sanitizer4 in 1 CARTONSPRAY42
77385-028-05hand sanitizer160 in 1 PACKAGESPRAY1602
77385-028-29hand sanitizer800 in 1 PACKAGESPRAY8002
77385-028-29hand sanitizer20 in 1 CARTONSPRAY202
77385-033-76Hand Sanitizer4 in 1 CARTONGEL42
77385-033-76Hand Sanitizer160 in 1 CASEGEL1602
77385-034-13Hand Sanitizer800 in 1 CASEGEL8002
77385-034-13Hand Sanitizer20 in 1 CARTONGEL202
77385-057-38Hand Sanitizer160 in 1 CASEGEL1602
77385-057-38Hand Sanitizer4 in 1 CARTONGEL42
77385-057-52Hand Sanitizer800 in 1 CASEGEL8002
77385-057-52Hand Sanitizer20 in 1 CARTONGEL202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77385-028HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER (ETHYL ALCOHOL) GEL HAND SANITIZER (ALCOHOL) SPRAY [CAMDEN PASSAGE INC.]2Legacy NDC, 4 package rows20200516_a55fae03-213c-61df-e053-2995a90a5a47.zip
77385-033HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER (ETHYL ALCOHOL) GEL HAND SANITIZER (ALCOHOL) SPRAY [CAMDEN PASSAGE INC.]2Legacy NDC, 2 package rows20200516_a55fae03-213c-61df-e053-2995a90a5a47.zip
77385-034HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER (ETHYL ALCOHOL) GEL HAND SANITIZER (ALCOHOL) SPRAY [CAMDEN PASSAGE INC.]2Legacy NDC, 2 package rows20200516_a55fae03-213c-61df-e053-2995a90a5a47.zip
77385-057HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER (ETHYL ALCOHOL) GEL HAND SANITIZER (ALCOHOL) SPRAY [CAMDEN PASSAGE INC.]2Legacy NDC, 4 package rows20200516_a55fae03-213c-61df-e053-2995a90a5a47.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
77385-05777385-057-38, 77385-057-52
77385-03377385-033-76
77385-03477385-034-13
77385-02877385-028-29, 77385-028-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
a5b3455a-e847-7d4b-e053-2995a90adee3a55fae03-213c-61df-e053-2995a90a5a472020-05-15WarningsExact identifier
spl id: a5b3455a-e847-7d4b-e053-2995a90adee3
spl set id: a55fae03-213c-61df-e053-2995a90a5a47

Reported adverse events (FAERS/openFDA)#

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