Burger Time -9413

Burger Time -9413
SPL v2
SPL
SPL Set ID bdea9a5e-bcec-43ee-9de4-658d100b4a7e
Route
TOPICAL
Published
Effective Date 2018-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (17.57 g)
Inactive Ingredients
Water Aloe Vera Leaf Carboxypolymethylene Glycerin Propylene Glycol Trolamine .alpha.-tocopherol Acetate Fd&c Yellow No. 5 Fd&c Blue No. 1 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-01

Description

Drug Facts

Purpose

Antimicrobial


Medication Information

Indications and Usage

Use hand sanitizer to help reduce bacteria on skin.

Purpose

Antimicrobial

Dosage and Administration

Directions

■ Wet hands thoroughly with product and rub into skin until dry.

■ Children 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 Yellow No. 5, FD&C Blue No. 1

Warning

Flammable Keep away from heat and flame

Active Ingredients

Ethyl Alcohol  62%

Product Labels For:

Burger Time Hand Sanitizer Label

Burger Time

HAND SANITIZER

Drug Facts

Active

Ingredients

Ethyl Alcohol 62.0%

Purpose

Antimicrobial

Use hand sanitizer

to help reduce

bacteria on skin.

ADDITIONAL DRUG FACTS

Distributed By:

Personal Care Products, LLC

Troy, Michigan 48084

Made in China

Drug Facts

(continued)

Flammable Keep

away from heat and

flame

When using this

product avoid contact

with eyes. If contact

occurs, rinse

thoroughly with water.

Stop use and ask

doctor if irritation or

redness develops

Keep out of reach

of children.

If swallowed, get

medical help or

contact a Poison

Control Center

right away.

Drug Facts

(continued)

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.

Inactive

Ingredients

Water (Aqua), Aloe

Barbadensis Leaf Juice,

Carbomer, Fragrance,

Glycerin, Propylene

Glycol, Triethanolamine,

Tocopheryl Acetate

FD&C Yellow No. 5,

FD&C Blue No. 1

Fresh Fries Hand Sanitizer Label

Pizza Party Hand Sanitizer Label



Sparkled Donut Hand Sanitizer Label


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 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.

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 Yellow No. 5, FD&C Blue No. 1

Purpose

Antimicrobial

Warning

Flammable Keep away from heat and flame

Active Ingredients

Ethyl Alcohol  62%

Product Labels For: (Product Labels for:)

Burger Time Hand Sanitizer Label

Burger Time

HAND SANITIZER

Drug Facts

Active

Ingredients

Ethyl Alcohol 62.0%

Purpose

Antimicrobial

Use hand sanitizer

to help reduce

bacteria on skin.

ADDITIONAL DRUG FACTS

Distributed By:

Personal Care Products, LLC

Troy, Michigan 48084

Made in China

Drug Facts

(continued)

Flammable Keep

away from heat and

flame

When using this

product avoid contact

with eyes. If contact

occurs, rinse

thoroughly with water.

Stop use and ask

doctor if irritation or

redness develops

Keep out of reach

of children.

If swallowed, get

medical help or

contact a Poison

Control Center

right away.

Drug Facts

(continued)

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.

Inactive

Ingredients

Water (Aqua), Aloe

Barbadensis Leaf Juice,

Carbomer, Fragrance,

Glycerin, Propylene

Glycol, Triethanolamine,

Tocopheryl Acetate

FD&C Yellow No. 5,

FD&C Blue No. 1

Fresh Fries Hand Sanitizer Label

Pizza Party Hand Sanitizer Label



Sparkled Donut Hand Sanitizer Label


Advanced Ingredient Data


Raw Label Data

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