Disney Villains Maleficent Hand Sanitizer, Dark Fruits

Disney Villains Maleficent Hand Sanitizer, Dark Fruits by

Drug Labeling and Warnings

Disney Villains Maleficent Hand Sanitizer, Dark Fruits by is a Otc medication manufactured, distributed, or labeled by Mad Beauty USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DISNEY VILLAINS MALEFICENT HAND SANITIZER, DARK FRUITS- alcohol gel 
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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Disney Villains Maleficent Hand Sanitizer, Dark Fruits

DRUG FACTS

Active Ingredient

Ethylalcohol 69%

Purpose

Antimicrobial

Uses

Reduces bacteria on hands.

Warnings

Flammable. Keep away from source of ignition or flame.

For external use only.

Do not use

on open skin wound.

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.

Directions

Place pea sized drop onto hands.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30°C (59-86°F).

Avoid freezing and excessive heat above 40°C (104°F). 

Inactive Ingredients

Water(Aqua)/Eau, Pentylene Glycol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylene Glycol, Fragrance(Parfum), Sodium Hydroxide, Aloe Barbadensis(Aloe Vera) Leaf Extract.

Questions or Comments

MAD BEAUTY USA LLC 1030 SALEM ROAD
UNION NJ 07083 MARYLAND
TEL (844) 995 1701

Package Labeling:

DISNEY VILLAINS MALEFICENT HAND SANITIZER, DARK FRUITS 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78789-002
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)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78789-002-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/01/2020	12/31/2024

Labeler - Mad Beauty USA LLC (117508758)

Revised: 12/2021

Document Id: d2b8505a-27d9-d4d3-e053-2a95a90a568d

34390-5

Set id: a93cc9f9-6e42-bd9b-e053-2a95a90a208c

Version: 2

Effective Time: 20211209