FDA.reportPublic FDA data

100% Pure Hand Sanitizer Hydrating Gel

Manufacturer
Purity Cosmetics | Our Babylon LLC
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:44:54

Label at a glance#

Product100% Pure Hand Sanitizer Hydrating
Active ingredientALCOHOL
Label structure13 sections

Indications and uses

For cleaning hands when water is not available to help reduce bacteria on the skin. Recommended for repeated use.

Dosage and administration

Dispense directly on hands and rub in thoroughly. For children under 6, use adult supervision. Not recommended for infants.

Storage and handling

Flammable, keep away from fire, sparks, and sources of ignition. Do not store above 104°F/40°C.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For cleaning hands when water is not available to help reduce bacteria on the skin. Recommended for repeated use.

Warnings:

WARNINGS SECTION

  • ​For external use only.

STORAGE AND HANDLING SECTION

  • Flammable, keep away from fire, sparks, and sources of ignition.
  • Do not store above 104°F/40°C.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

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 immediately.

OTHER SAFETY INFORMATION

  • Avoid contact with broken skin.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Directions:

DOSAGE & ADMINISTRATION SECTION

Dispense directly on hands and rub in thoroughly. For children under 6, use adult supervision. Not recommended for infants.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice*, Glycerin, Hydroxypropyl Guar, Citric Acid, Aqua (Water) *Organic Ingredient

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100% Pure Hand Sanitizer Hydrating Gel

Product NDC 52667-011 LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52667-011-012024-12-19C16284748780-1f386c64a-1f6d-0266-e053-dadaa90a7c1a100% Pure Hand Sanitizer Hydrating Gel
52667-011-022024-12-19C16284748780-1f386c64a-1f6d-0266-e053-dadaa90a7c1a100% Pure Hand Sanitizer Hydrating Gel
52667-011-012023-01-30C16284748780-1f386c64a-1f6d-0266-e053-dadaa90a7c1a100% Pure Hand Sanitizer Hydrating Gel
52667-011-022023-01-30C16284748780-1f386c64a-1f6d-0266-e053-dadaa90a7c1a100% Pure Hand Sanitizer Hydrating Gel

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52667-01152667-011-01, 52667-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
GUARAPROLOSE (1300 MPA.S AT 1%)1530WMS90SIACT
ALCOHOL3K9958V90MACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT

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
29a4f3ff-0672-fa15-e063-6394a90af13dabbe7ae3-bd3a-2089-e053-2a95a90af7072024-12-19WarningsExact identifier
spl id: 29a4f3ff-0672-fa15-e063-6394a90af13d
spl set id: abbe7ae3-bd3a-2089-e053-2a95a90af707

Reported adverse events (FAERS/openFDA)#

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