SHEA BUTTER SCENTED HAND SANITIZER

Manufacturer: FOURSTAR GROUP USA, INC.
Effective date: 2025-02-25
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:56:04

Label at a glance#

ProductSHEA BUTTER SCENTED HAND SANITIZER

Active ingredientALCOHOL

Label structure7 sections

Indications and uses

hand sanitizer to help reduce bacteria on skin

Dosage and administration

Put a dime sized drop onto hands and rub together briskly until dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol, 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

hand sanitizer to help reduce bacteria on skin

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, excessive redness or rash develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Put a dime sized drop onto hands and rub together briskly until dry.

Other information

SPL UNCLASSIFIED SECTION

Store below 110°F (43°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, propylene glycol, acrylates/c10-30 alkyl acrylate crosspolymer, fragrance, aminomethyl propanol

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package3Inner Package3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
582753	ethanol 70 % Topical Solution	PSN	2
582753	ethanol 0.7 ML/ML Topical Solution	SCD	2
582753	ethanol 70 % Topical Solution	SY	2
582753	ethyl alcohol 70 % Topical Solution	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80684-122-00	2025-02-25	C162847	48780-1	2cef2736-8d43-d83d-e063-dadaa90ab31f	SHEA BUTTER SCENTED HAND SANITIZER
80684-122-00	2025-01-30	C162847	48780-1	2cef2736-8d43-d83d-e063-dadaa90ab31f	SHEA BUTTER SCENTED HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80684-122-00	SHEA BUTTER SCENTED HAND SANITIZER	89 mL in 1 BOTTLE	LIQUID	89		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80684-122	SHEA BUTTER SCENTED HAND SANITIZER (ALCOHOL) LIQUID [FOURSTAR GROUP USA, INC.]	2	Current NDC, 1 package rows	20250227_669451fa-7557-4ef5-a668-fe4fea1f0c9b.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

SHEA BUTTER SCENTED HAND SANITIZER
ALCOHOL
WATER
GLYCERIN
PROPYLENE GLYCOL
AMINOMETHYLPROPANOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80684-122	80684-122-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
ALCOHOL	3K9958V90M	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHEA BUTTER SCENTED HAND SANITIZER	ALCOHOL	FOURSTAR GROUP USA, INC.	669451fa-7557-4ef5-a668-fe4fea1f0c9b	2025-02-25	Warnings	Exact identifier ndc (package): 80684-122-00 ndc (product): 80684-122 ndc11 (package): 80684012200 spl id: 2ef27711-9312-b8c7-e063-6294a90a9bf1 spl set id: 669451fa-7557-4ef5-a668-fe4fea1f0c9b

Reported adverse events (FAERS/openFDA)#

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