Naked X Restore Hand Sanitizer

Manufacturer: Essations Inc.
Effective date: 2023-01-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:53:44

Label at a glance#

ProductNaked X Restore Hand Sanitizer

Active ingredientALCOHOL

Label structure9 sections

Indications and uses

• For handwashing to decrease bacteria on the skin. • Moisturinzing, cleansing solution. • Repeated use encouraged.

Dosage and administration

• Apply a generous amount to one palm. • Rub to saturate both palms. • Rub across back of hands, between fingers, & around thumbs covering all surafces until they feel dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70.0% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

• For handwashing to decrease bacteria on the skin. • Moisturinzing, cleansing solution. • Repeated use encouraged.

Warnings

WARNINGS SECTION

For external use only.

Flammable; keep away from heat, fire, and flame.

Avoid contact with eyes, ears, and mouth. In case of eye contact, flush thoroughly with water for 10 minutes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, immediately seek medical attention or contact poison control.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply a generous amount to one palm. • Rub to saturate both palms. • Rub across back of hands, between fingers, & around thumbs covering all surafces until they feel dry.

Other information

SPL UNCLASSIFIED SECTION

• Store at 20°C to 25°C (68°F to 77°F)
• May discolor certain surfaces and fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D.I. Water (Aqua), Polysorbate-20, Fragrance, Carbomer, Triethanolamine.

SPL UNCLASSIFIED SECTION

Children under the age of 6 years old should be supervised when using this product. Do not use on children under 2 months of age, or on open skin wounds.

Package Labeling:64ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

Package Labeling:946ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581662	ethanol 70 % Topical Gel	PSN	3
581662	ethanol 0.7 ML/ML Topical Gel	SCD	3
581662	ethanol 70 % Topical Gel	SY	3
581662	ethyl alcohol 70 % Topical Gel	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79116-000-01	2025-01-30	C162847	48780-1	f386c64a-25ad-0266-e053-dadaa90a7c1a	Naked X Restore Hand Sanitizer
79116-000-02	2025-01-30	C162847	48780-1	f386c64a-25ad-0266-e053-dadaa90a7c1a	Naked X Restore Hand Sanitizer
79116-000-01	2023-02-06	C162847	48780-1	f386c64a-25ad-0266-e053-dadaa90a7c1a	Naked X Restore Hand Sanitizer
79116-000-02	2023-02-06	C162847	48780-1	f386c64a-25ad-0266-e053-dadaa90a7c1a	Naked X Restore Hand Sanitizer
79116-000-01	2023-01-30	C162847	48780-1	f386c64a-25ad-0266-e053-dadaa90a7c1a	Naked X Restore Hand Sanitizer
79116-000-02	2023-01-30	C162847	48780-1	f386c64a-25ad-0266-e053-dadaa90a7c1a	Naked X Restore Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79116-000-01	Naked X Restore Hand Sanitizer	64 mL in 1 BOTTLE	GEL	64		3
79116-000-02	Naked X Restore Hand Sanitizer	946 mL in 1 BOTTLE	GEL	946		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79116-000	NAKED X RESTORE HAND SANITIZER (ALCOHOL) GEL [ESSATIONS INC.]	3	Legacy NDC, 2 package rows	20230207_ab8508f2-2a22-2634-e053-2a95a90ad55d.zip

Products#

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

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

Naked X Restore Hand Sanitizer
ALCOHOL
WATER
POLYSORBATE 20
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79116-000	79116-000-01, 79116-000-02

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
POLYSORBATE 20	7T1F30V5YH	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
TROLAMINE	9O3K93S3TK	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
f2b6fbd5-10f5-8879-e053-2a95a90a9ba9			ab8508f2-2a22-2634-e053-2a95a90ad55d	2023-01-20	Warnings	Exact identifier spl id: f2b6fbd5-10f5-8879-e053-2a95a90a9ba9 spl set id: ab8508f2-2a22-2634-e053-2a95a90ad55d

Reported adverse events (FAERS/openFDA)#

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