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Drug Facts
Burger Time
FDA Label NDC 29500-9413
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gl 360 for the product Burger Time (NDC 29500-9413). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, indications & usage, warning, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Ethyl Alcohol 62%
Purpose
Antimicrobial
Indications & Usage
Use hand sanitizer to help reduce bacteria on skin.
Warning
Flammable Keep away from heat and flame
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask doctor if irritation or redness develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & 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.
Inactive Ingredient
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
Product Labels For:Burger Time Fresh Fries Pizza Party Sparkled Donut
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
Brgrtime (Brgrtime)
Fresh Fries Hand Sanitizer Label
Freshfries (Freshfries)
Pizza Party Hand Sanitizer Label
Pizzaparty (Pizzaparty)
Sparkled Donut Hand Sanitizer Label
Sparklddonut (Sparklddonut)
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