FDA.reportPublic FDA data

Safety First

Manufacturer
Clean Beauty Concepts
Effective date
2020-10-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:25

Label at a glance#

ProductSafety First
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 age 6 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

The sanitizer wipes is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  1. Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (75%, 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
  3. Hydrogen peroxide
  4. Sterile distilled water or boiled cold water. (27.465%)
  5. Fragrance (Parfum)
  6. Aloe vera leaf extract
  7. Tocopheryl Acetate (Vitamin E)
  8. Aminomethyl Propanol

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin. 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

  • on 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 age 6 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

water(aqua), glycerin, aloe vera barbadensis (aloe vera) leaf extract, tocopheryl acetate (Vitamine E), hydrogen peroxide, Aminomethyl Propanol, fragrance(parfum)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3875 mL NDC: 76665-011-01

1 gallon label1 gallon label

473 mL NDC: 76665-011-16

16 oz label16 oz label

236mL NDC: 76665-011-08

8oz label8oz label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN1
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD1
808520isopropyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76665-011-012022-01-28C16284748780-1d6a99b39-fccc-a426-e053-dadaa90af4c2b168f919-040a-44f0-e053-2a95a90a8c51
76665-011-082022-01-28C16284748780-1d6a99b39-fccc-a426-e053-dadaa90af4c2b168f919-040a-44f0-e053-2a95a90a8c51
76665-011-162022-01-28C16284748780-1d6a99b39-fccc-a426-e053-dadaa90af4c2b168f919-040a-44f0-e053-2a95a90a8c51

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76665-011-01Safety First3875 mL in 1 BOTTLE, PUMPLIQUID38751
76665-011-08Safety First236 mL in 1 BOTTLE, PUMPLIQUID2361
76665-011-16Safety First473 mL in 1 BOTTLE, PUMPLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76665-011SAFETY FIRST (ALCOHOL) LIQUID [CLEAN BEAUTY CONCEPTS]1Legacy NDC, 3 package rows20201012_b168f919-040a-44f0-e053-2a95a90a8c51.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76665-01176665-011-01, 76665-011-16, 76665-011-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS SMITHII OILX4023CB3OKIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT

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
b168ee44-3270-0c93-e053-2995a90a8fd1b168f919-040a-44f0-e053-2a95a90a8c512020-10-11WarningsExact identifier
spl id: b168ee44-3270-0c93-e053-2995a90a8fd1
spl set id: b168f919-040a-44f0-e053-2a95a90a8c51

Reported adverse events (FAERS/openFDA)#

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