Moisturizing Hand Sanitizer

Manufacturer
Molecular GPS Enterprises dba Clayton Chemical
Effective date
2022-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:11

Label at a glance#

ProductMoisturizing Hand Sanitizer
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 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 CFR Part333A and 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, ISO9001, and EN13485:

  1. Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (2.0% v/v).
  3. Lavender oil ((0.2% v/v).
  4. Guar Gum (0.025% wt/v).
  5. Glacial acetic acid (000% v/v)
  6. Hydrogen peroxide (0.15% v/v).
  7. Collagen (0.0003% wt/v).
  8. Purified 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

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

59 ml NDC 78548-5102-1 back label59 ml NDC 78548-5102-1 back label

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

3800 ml NDC 78548-5102-43800 ml NDC 78548-5102-4

3800 ml NDC 78548-5102-4 front label3800 ml NDC 78548-5102-4 front label

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

946 ml NDC 78548-5102-3946 ml NDC 78548-5102-3

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, lavender oil, guar gum, glacial acetic acid, hydrogen peroxide, collagen, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 ml NDC: 78548-5102-1

946 ml NDC: 78548-5102-3

3840 ml NDC: 78548-5102-4

59 ml NDC 78548-5102-159 ml NDC 78548-5102-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN2
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD2
808520isopropyl alcohol 70 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78548-5102-12023-07-28C16284748780-10191ceaa-6af5-198a-e063-dbdaa90aec3eMoisturizing Hand Sanitizer
78548-5102-32023-07-28C16284748780-10191ceaa-6af5-198a-e063-dbdaa90aec3eMoisturizing Hand Sanitizer
78548-5102-42023-07-28C16284748780-10191ceaa-6af5-198a-e063-dbdaa90aec3eMoisturizing Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78548-5102-1Moisturizing Hand Sanitizer59 mL in 1 BOTTLE, DROPPERLIQUID592
78548-5102-3Moisturizing Hand Sanitizer946 mL in 1 BOTTLE, PLASTICLIQUID9462
78548-5102-4Moisturizing Hand Sanitizer3800 mL in 1 BOTTLE, PLASTICLIQUID38002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78548-5102MOISTURIZING HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [MOLECULAR GPS ENTERPRISES DBA CLAYTON CHEMICAL]2Legacy NDC, 3 package rows20220119_aaacab13-1758-14cc-e053-2a95a90a3406.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78548-510278548-5102-1, 78548-5102-3, 78548-5102-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
d5e2f6bf-7ef0-99b8-e053-2a95a90a4e67aaacab13-1758-14cc-e053-2a95a90a34062022-01-18WarningsExact identifier
spl id: d5e2f6bf-7ef0-99b8-e053-2a95a90a4e67
spl set id: aaacab13-1758-14cc-e053-2a95a90a3406

Reported adverse events (FAERS/openFDA)#

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