DERMESSENTIALS ADVANCED HAND SANITIZER- alcohol gel

DermEssentials Advanced Hand Sanitizer by

Drug Labeling and Warnings

DermEssentials Advanced Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SmartScience Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

• to decrease bacteria on the skin that could cause disease
• recommended for repeated use

Warnings

For external use only: hands

• Flammable, keep away from fire or flame.

When Using this product

• keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• avoid contact with broken skin
• do not inhale or ingest

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hrs

Keep out of reach of children

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

Directions

• wet hands thoroughly with product and allow to dry without wiping
• for children under 6, use only under adult supervision
• not recommended for infants

Other Information

• do not store above 105 F
• may discolor some fabrics
• harmful to wood finishes and plastic

Inactive Ingredients

Purified Water, Aloe Vera, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Triethanolamine, Vitamin E, EDTA

Questions? Comments?

813-925-8454

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

DermEssentials™

Advanced
GEL
Hand Sanitizer

KILLS 99.99% OF MOST ILLNESS
CAUSING GERMS

• 70% Ethyl Alcohol
• With Vitamin E and Aloe
• Leaves hands soft
• Fast and Effective

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

DERMESSENTIALS ADVANCED HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64479-501
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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64479-501-01	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/10/2020

Labeler - SmartScience Laboratories, Inc. (035907919)