Claims

MOISTURIZING HAND SANITIZER WITH VITAMIN E

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

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

Warnings

For exterenal 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 hours

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 105⁰F
may discolor some fabrics
harmful to wood finishes and plastics

Inactive ingredients

water, carbomer or acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, glycerin, isopropyl myristate, tocopheryl acetate

Claims

*Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

ADVERSE REACTION

DSP-TN-21091 DSP-MO-20087

Distributed By:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Principal panel display

SIMPLY

U ®

Moisturizing

Hand

Sanitizer

With Vitamin E

Kills 99.99% of germs*

32 FL OZ (1 QT) 946 mL

image description

ALCOHOL
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11344-849
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11344-849-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/29/2020
2	NDC:11344-849-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/29/2020
3	NDC:11344-849-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	04/29/2020

Labeler - Nice-Pak Products, LLC (119091520)

Registrant - Nice-Pak Products, LLC (119091520)

Name	Address	ID/FEI	Business Operations
Establishment
Nice-Pak Products, LLC		119091514	manufacture(11344-849)

Name	Address	ID/FEI	Business Operations
Establishment
Nice-Pak Products, LLC		119091520	manufacture(11344-849)

Simply U 849.001/849AB-AG,BA Moisturizing Hand Sanitizer

Claims

Active ingredient

Purpose

Uses

Warnings

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Claims

ADVERSE REACTION

Principal panel display

Simply U 849.001/849AB-AG,BA
Moisturizing Hand Sanitizer