I Love Xmas Polar Bear Moisturizing Hand Sanitizer, Marshmallow

I Love Xmas Polar Bear Moisturizing Hand Sanitizer Marshmallow by

Drug Labeling and Warnings

I Love Xmas Polar Bear Moisturizing Hand Sanitizer Marshmallow by is a Otc medication manufactured, distributed, or labeled by Mad Beauty USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

I LOVE XMAS POLAR BEAR MOISTURIZING HAND SANITIZER MARSHMALLOW- alcohol spray 
Mad Beauty USA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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I Love Xmas Polar Bear Moisturizing Hand Sanitizer, Marshmallow

DRUG FACTS

Active Ingredient

Ethylalcohol 69%

Purpose

Antimicrobial

Uses

Reduce bacteria on hands.

Warnings

Flammable. Keep away from source of Ignition or flame.

For external use only.

Do not use

on open skin wounds

When using this product

keep out of eyes.

Stop use and ask a doctor

if irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a doctor immediately.

Inactive Ingredients

Water(Aqua)/Eau, Propylene Glycol, Isopropylene Glycol, Isopropyl Alcohol, Glycerin, acrylates/C10-30 Alkyl Acrylate Crosspolymer, Isopropyl Myristate, Tocopheryl Acetate(Vitamin E), Fragrance(parfum), Butylene Glycol, Barbadensis (Aloe Vera)Leaf Extract.

Directions

Spray into hands. Rub until absorbed.

Supervise children under 6 years of age when using this produt to avoid swallowing.

Other Information

Store between 15-30°C (59-86°F). Avoid freezing and excessive heat above 40°C (104°F).

Questions or Comments

MAD BEAUTY USA LLC

1030 SALEM ROAD

UNION NJ 07083 MARYLAND

TEL (844) 995 1701

Package Labeling:

I LOVE XMAS POLAR BEAR MOISTURIZING HAND SANITIZER MARSHMALLOW 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78789-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.69 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78789-016-00	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2020	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/20/2020	12/31/2024

Labeler - Mad Beauty USA LLC (117508758)

Revised: 12/2021

Document Id: d2b7b5e6-35a7-d534-e053-2995a90a3689

34390-5

Set id: ab328e65-c497-ba44-e053-2995a90a85bf

Version: 2

Effective Time: 20211209