NAKED X RESTORE HAND SANITIZER- alcohol gel

Naked X Restore Hand Sanitizer by

Drug Labeling and Warnings

Naked X Restore Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Essations Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 70.0% v/v

Purpose

Antimicrobial

Uses

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

Warnings

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

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

Keep out of reach of children.

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

Directions

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

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

Inactive ingredients

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 Labeling:946ml

INGREDIENTS AND APPEARANCE

NAKED X RESTORE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79116-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79116-000-01	64 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 79116-000-02	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/30/2020

Labeler - Essations Inc. (084183600)

Establishment
Name	Address	ID/FEI	Business Operations
Essations Inc.		084183600	manufacture(79116-000) , label(79116-000) , pack(79116-000)