FDA.reportPublic FDA data

PFA STRONGHOLD SANITIZING HANDLOTION SHEA BUTTER

Manufacturer
STRONGHOLD TRADING LLC | S-ONE PHARMACEUTICAL INC
Effective date
2023-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:05

Label at a glance#

ProductPFA STRONGHOLD SANITIZING HANDLOTION SHEA BUTTER
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Put enough product in the palm to cover hands & rub together briskly the liquid is dry Children under 6 should be supervised when using Sanitizers.

Storage and handling

Store below 77°F (25°C) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Sanitizer

Use

DOSAGE & ADMINISTRATION SECTION

Hand sanitizing to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

In case of contact, flush eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develops and persists.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

INDICATIONS & USAGE SECTION

  • Put enough product in the palm to cover hands & rub together briskly the liquid is dry
  • Children under 6 should be supervised when using Sanitizers.

Other information

STORAGE AND HANDLING SECTION

  • Store below 77°F (25°C)
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, PEG-60 Hydrogenated Castor Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Ammonium Polyacryloyldimethyl Taurate, Caprylic/Capric Triglyceride, Centella Asiatica Extract, Cocos Nucifera (Coconut) Oil, Polysorbate 80, Fragrance, Benzyl Salicylate, Coumarin, Limonene, Linalool

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80969-007-0180969-007-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637077ethanol 62 % Topical LotionPSN2
637077ethanol 0.62 ML/ML Topical LotionSCD2
637077ethanol 62 % Topical LotionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80969-007-012025-01-30C16284748780-1f386c649-9ecb-0266-e053-dadaa90a7c1a80969-007-01 PFA STRONGHOLD SANITIZING HAND LOTION_SHEA BUTTER
80969-007-012023-02-13C16284748780-1f386c649-9ecb-0266-e053-dadaa90a7c1a80969-007-01 PFA STRONGHOLD SANITIZING HAND LOTION_SHEA BUTTER
80969-007-012023-01-30C16284748780-1f386c649-9ecb-0266-e053-dadaa90a7c1a80969-007-01 PFA STRONGHOLD SANITIZING HAND LOTION_SHEA BUTTER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80969-007-01PFA STRONGHOLD SANITIZING HANDLOTION SHEA BUTTER2 mL in 1 POUCHLOTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80969-007PFA STRONGHOLD SANITIZING HANDLOTION SHEA BUTTER (ALCOHOL) LOTION [STRONGHOLD TRADING LLC]2Legacy NDC, 1 package rows20230214_d1fdd2c5-2360-6084-e053-2995a90aa2f9.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80969-00780969-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 60 HYDROGENATED CASTOR OIL02NG325BQGIACT
LINALOOL, (+/-)-D81QY6I88EIACT
COUMARINA4VZ22K1WTIACT
LIMONENE, (+)-GFD7C86Q1WIACT
SHEA BUTTERK49155WL9YIACT
POLYSORBATE 806OZP39ZG8HIACT
ALCOHOL3K9958V90MACTIB
BENZYL SALICYLATEWAO5MNK9TUIACT
COCONUT OILQ9L0O73W7LIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 100 STEARATEYD01N1999RIACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)F01RIY4371IACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT

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
f321f8f3-8625-147a-e053-2995a90a9b59d1fdd2c5-2360-6084-e053-2995a90aa2f92023-01-25WarningsExact identifier
spl id: f321f8f3-8625-147a-e053-2995a90a9b59
spl set id: d1fdd2c5-2360-6084-e053-2995a90aa2f9

Reported adverse events (FAERS/openFDA)#

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