FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Clearbrooke Technologies LLC | Clearbrooke Enterprises LLC
Effective date
2021-07-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:39:38

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product and allow it to dry without wiping For children under 6 years of age use only under adult supervision not recommended for infants

Storage and handling

Do not store above 105F may discolor some fabrics harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

  • To decrease bacteria on skin that could cause disease
  • Recommended for repeated use when soap and water are not available.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow it to dry without wiping
  • For children under 6 years of age use only under adult supervision
  • not recommended for infants

Warnings

WARNINGS SECTION

For external use only: hands.

Flammable. Keep away from heat or flame

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.

Avoid contact with broken skin

Do not inhale or ingest

OTC - STOP USE SECTION

Stop use and ask a doctor if:

irritation or rash occurs

condition persists 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.

Other information

STORAGE AND HANDLING SECTION

  • Do not store above 105F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, purified water, Polyacrylamide, C13 - 14 isoparaffin, Laureth-7

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16 oz NDC: 75366-330-01 75366-330-0175366-330-01

32 oz NDC: 75366-330-02 75366-330-0275366-330-02

330 gal NDC: 75366-330-03 75366-330-0375366-330-03

16 oz NDC 75366-331-01 75366-331-0175366-331-01

32 oz NDC 75366-331-02 75366-331-0275366-331-02

330 gal NDC 75366-331-03 75366-331-0375366-331-03

1 gal NDC 75366-331-04 75366-331-0475366-331-04

5 gal NDC 75366-331-05 75366-331-0575366-331-05

55 gal NDC 75366-331-06 75366-331-0675366-331-06

.5 gal NDC 75366-331-07 75366-331-0775366-331-07

16 oz NDC 75366-332-01 75366-332-0175366-332-01

32 oz NDC 75366-332-02 75366-332-0275366-332-02

330 gal NDC 75366-332-03 75366-332-0375366-332-03

64 oz NDC 75366-332-04 75366-332-0475366-332-04

1 gal NDC 75366-332-05 75366-332-0575366-332-05

5 gal NDC 75366-332-06 75366-332-0675366-332-06

55 gal NDC 75366-332-07 75366-332-0775366-332-07

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75366-330-012021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-330-022021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-330-032021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-331-012021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-331-022021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-331-032021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-332-012021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-332-022021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-332-032021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-332-042021-07-26C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-330-012021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-330-022021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-330-032021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-331-012021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-331-022021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-331-032021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-332-012021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-332-022021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-332-032021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2
75366-332-042021-07-23C16284748780-1c7ccaba7-1461-fd44-e053-dadaa90aa01bMARKETING COMPLETED Hand Sanitizer HUMAN OTC DRUG LABEL Registration 2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75366-33075366-330-01, 75366-330-02, 75366-330-03
75366-33175366-331-01, 75366-331-02, 75366-331-03, 75366-331-04, 75366-331-05, 75366-331-06, 75366-331-07
75366-33275366-332-01, 75366-332-03, 75366-332-02, 75366-332-04, 75366-332-05, 75366-332-06, 75366-332-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURETH-7Z95S6G8201IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
C13-14 ISOPARAFFINE4F12ROE70IACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
ETHYL METHYLPHENYLGLYCIDATEUD51D5KR4AIACT
LAURETH-7Z95S6G8201IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
C13-14 ISOPARAFFINE4F12ROE70IACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
COUMARINA4VZ22K1WTIACT
METHYL CINNAMATE533CV2ZCQLIACT
ETHYL MALTOLL6Q8K29L05IACT
ALLYL HEXANOATE3VH84A363DIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LAURETH-7Z95S6G8201IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
C13-14 ISOPARAFFINE4F12ROE70IACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
ETHYL MALTOLL6Q8K29L05IACT
BENZYL BENZOATEN863NB338GIACT
LINALOOL, (+/-)-D81QY6I88EIACT
MYRCENE3M39CZS25BIACT
CITRALT7EU0O9VPPIACT
LINALYL ACETATE5K47SSQ51GIACT

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
aee58c44-5dbc-8acb-e053-2a95a90a23afa392dc97-ac17-e755-e053-2995a90a2e482021-07-23WarningsExact identifier
spl id: aee58c44-5dbc-8acb-e053-2a95a90a23af
spl set id: a392dc97-ac17-e755-e053-2995a90a2e48

Reported adverse events (FAERS/openFDA)#

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