DermEssentials Advanced Hand Sanitizer.docx

DermEssentialsTM Advanced Hand Sanitizer 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

· iITitation 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 d1y 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

· haJTllful to wood finishes and plastic

Inactive Ingredients Purified Water, Aloe Vera, Glycerin, Aciylates/Cl0-30 Alkyl Ac1ylate Crosspolymer, Fragrance, Triethanolamine, Vitamin E, EDTA

Questions? Comments?

813-925-8454

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label DermEssentialsTM 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)

DermEssentials™ Advanced

CEL

Hand

Sanitizer

KILLS

99.99%

OF

MOST

I

LLNESS CAUSING GERMS

70%

Ethyl

Alcohol With

Vitamin

E and

Aloe Leaves hands soft Fast and

Effective

FL

OZ

(236 ml)

Drug

Facts Active

Ingredient Purpose Ethyl alcohol

70% v v .Anliseplic Uses to decrease bacteria on the skin that could cause disease recoovrendedfor repeated use Warnings For external use only:

hands

Flammable kee p away from fire or flame W hen

Using this product keep out of eyes In case of coofacl w.1h eyes flush thoroughly with waler avoid contact with broken sk in do nol inhale or ingesl Sto use and ask a doctor if ilritation and re dev Keep out of reach of children

If swallowed, gel medical help o r contact a

P oison Control

Center ri hliM'i!

Direction wet hands thotough ly wi1h product and allow t odry wi8iout wipmg for children under use only er adult supervision not recommended for infants Other

Information do not store above

F may discolor some fabrics harmfu l to wood finishes and plastic Inactive lng,edients P,.;fied

Water Aloe

Vera, Gq,rerin, Acryfates/C 0-30 Alkyl

Acrylate

Cros,;pofymer

Fragrance Triethanolamine

Vitamin

E

EDTA

SmartScience Laboratories 13760 Reptron Blvd Tampa

Fl ori d a 33626 Questions?

Comments?

925-8454

MADE

IN

USA

UUJ

II

50101

DERMESSENTIALS

ADVANCED

HAND

SANITIZER

alcohol gel Product

Information Product

Type Route of

Administration

HUMAN

OTC

DRUG

TOPICAL

J Item

Code

(Som·ce)

NDC:64479-

J Active

Ingredient/Active

Moiety Ingredient

Name I

ALCOHOL

(UNI!:

3K9958V90M)

(A

COHOL

UNll:3K9958V90M) Basis of

Strength

I

ALCO

HO

L

Strength l l'l- L i n mL _I Inactive Ingredients Ingredient Name

CARBOI\IER INTERPOLYMER

TYPE

A

(ALLYL

SUCROSE

CROSSLINKED) (UNII:

59TL3\VG5CO)

ALOE VERA LEAF (UNII: ZY81Z83H0X)

EDETATE

DISODilJM

ANHYDROUS

(UNIT:

8NLQ36F6MM)

Strength

.ALPHA.-TOCOPHEROL

ACETATE

(UNII:

9E8X80D2L0) j GLYCERIN(UNil:PDC6A3C

OO

X)

WATER (UNII: 059QF0KO0R)

TROLAMlL>'E

(UNII:

9O3K93S3TK

Lll\lONENE c

-(UNII:

GFD7C86Q

V)

Packaging

Item

Code Package

Description mL in

I

2°TLE,

PLASTIC;

Ty!'e

0:

Not m a binntion

Product Marketing

Start

Date 04110 Marketing

End

Date I l

I

NDC:6'.'.479-501-

Marketing

Information Marketing

Category I

OTC

monograph not final Application

Number or

Monograph

Citation I P•

Marketing Start Date 04110,2020 Marketing

End

Date L

Labeler - Sm311Science Laboratories, Inc. (035907919)

Revised: 5/2020 SmartScience Laboratories, Inc.

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