SPL v4
SPL
SPL Set ID 507284c2-de9a-4503-bb29-4eefe2e5184f
Route
TOPICAL
Published
Effective Date 2019-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (17.98 mL)
Inactive Ingredients
Water Aloe Vera Leaf Carboxypolymethylene Glycerin Propylene Glycol Trolamine .alpha.-tocopherol Acetate Fd&c Red No. 40 D&c Red No. 33 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Flammable Keep

away from heat and flame

Indications and Usage

Use hand sanitizer

to help reduce

bacteria on skin.

Dosage and Administration

Directions

■ Wet hands

thoroughly with

product and rub

into skin until dry.

■ Children under

6 years of age

should be

supervised by an

adult when using.



Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach

of children.

If swallowed, get

medical help or

contact a Poison

Control center

right away.

Section 50566-9

Stop use and ask

doctor if irritation or

redness develops.

Section 50567-7

When using this

product avoid contact

with eyes. If contact

occurs, rinse

thoroughly with water.

Section 51727-6

Inactive

Ingredients

Water (Aqua), Aloe

Barbadensis Leaf

Juice, Carbomer,

Fragrance, Glycerin,

Propylene Glycol,

Triethanolamine,

Tocopheryl Acetate,

FD&C Red No. 40, D&C

Red No.33

Section 55105-1



Purpose  

Antimicrobial

Section 55106-9



Active ingredients  

Ethyl Alcohol 62.0%

Principal Display Package

Purrfect

Cherry

HAND SANITIZER

1 FL OZ (29 mL)

PEEL UP TO SEE

ADDITIONAL DRUG FACTS

Distributed By:

GL360, LLC

Troy Michigan, 48084

Made in China

Product Package

3 29500 00210 0

Sunny

Tropicolada

HAND SANITIZER

1 FL OZ (29 mL

PEEL UP TO SEE

ADDITIONAL DRUG FACTS

Distributed By:

GL360, LLC

Troy Michigan, 48084

Made in China

↓Product Package↓

3 29500 00211 7

res


Structured Label Content

Indications and Usage (34067-9)

Use hand sanitizer

to help reduce

bacteria on skin.

Dosage and Administration (34068-7)

Directions

■ Wet hands

thoroughly with

product and rub

into skin until dry.

■ Children under

6 years of age

should be

supervised by an

adult when using.



Warnings and Precautions (34071-1)

Flammable Keep

away from heat and flame

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach

of children.

If swallowed, get

medical help or

contact a Poison

Control center

right away.

Section 50566-9 (50566-9)

Stop use and ask

doctor if irritation or

redness develops.

Section 50567-7 (50567-7)

When using this

product avoid contact

with eyes. If contact

occurs, rinse

thoroughly with water.

Section 51727-6 (51727-6)

Inactive

Ingredients

Water (Aqua), Aloe

Barbadensis Leaf

Juice, Carbomer,

Fragrance, Glycerin,

Propylene Glycol,

Triethanolamine,

Tocopheryl Acetate,

FD&C Red No. 40, D&C

Red No.33

Section 55105-1 (55105-1)



Purpose  

Antimicrobial

Section 55106-9 (55106-9)



Active ingredients  

Ethyl Alcohol 62.0%

Principal Display Package

Purrfect

Cherry

HAND SANITIZER

1 FL OZ (29 mL)

PEEL UP TO SEE

ADDITIONAL DRUG FACTS

Distributed By:

GL360, LLC

Troy Michigan, 48084

Made in China

Product Package

3 29500 00210 0

Sunny

Tropicolada

HAND SANITIZER

1 FL OZ (29 mL

PEEL UP TO SEE

ADDITIONAL DRUG FACTS

Distributed By:

GL360, LLC

Troy Michigan, 48084

Made in China

↓Product Package↓

3 29500 00211 7

res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)