wellena skincare hand sanitizer

Manufacturer: Hormone Balance Nutritionals | NIKO Cosmetics
Effective date: 2020-05-08
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:10:18

Label at a glance#

Productwellena skincare hand sanitizer

Active ingredientALCOHOL

Label structure8 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

Contacts and useful links#

PhoneLabel contact646.580.0121

Label contents#

Full prescribing information#

Active Ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol - 70 % (v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

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

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

OTC - STOP USE SECTION

Stop using and ask a doctor if irritation or rash occurs. These may be signs of serious conditions.

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

SPL UNCLASSIFIED SECTION

Store between 15°-30°C (59°-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Xanthan Gum

wellena SKINCARE Hand Sanitizer - 120 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

wellena

SKINCARE

HAND SANITIZER

70% ALCOHOL BASE

120 mL / 4 fl oz

NDC: 77011-070-13

Questions or report any adverse reactions to:

646.580.0121

Made in Canada

Manufactured for:

Hormone Balance Nutritionals

3980 Broadway 103, #137

Boulder, CO 80304

hormonebalancenutrionals.com

NONGMO

CRUELTY FREE

GLUTEN FREE

WOMEN OWNED

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
582753	ethanol 70 % Topical Solution	PSN	3
582753	ethanol 0.7 ML/ML Topical Solution	SCD	3
582753	ethanol 70 % Topical Solution	SY	3
582753	ethyl alcohol 70 % Topical Solution	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77011-070-13	2022-01-28	C162847	48780-1	d6a99b39-bfd4-a426-e053-dadaa90af4c2	wellena SKINCARE Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77011-070-13	wellena skincare hand sanitizer	120 mL in 1 BOTTLE	LIQUID	120		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77011-070	WELLENA SKINCARE HAND SANITIZER (HAND SANITIZER) LIQUID [HORMONE BALANCE NUTRITIONALS]	3	Legacy NDC, 1 package rows	20200509_3f29b156-d829-4a56-ac40-b8eb8712db24.zip

Products#

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

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

wellena skincare hand sanitizer
Hand Sanitizer
WATER
XANTHAN GUM
GLYCERIN
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77011-070	77011-070-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
GLYCERIN	PDC6A3C0OX	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
a5286af3-f9fe-076f-e053-2995a90ae729			3f29b156-d829-4a56-ac40-b8eb8712db24	2020-05-08	Warnings	Exact identifier spl id: a5286af3-f9fe-076f-e053-2995a90ae729 spl set id: 3f29b156-d829-4a56-ac40-b8eb8712db24

Reported adverse events (FAERS/openFDA)#

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