All Hands Lychee & Asian Pear Moisturizing Hand Cleansing Gel with Alcohol

All Hands Lychee and Asian Pear Moisturizing Hand Cleansing Gel with Alcohol by

Drug Labeling and Warnings

All Hands Lychee and Asian Pear Moisturizing Hand Cleansing Gel with Alcohol by is a Otc medication manufactured, distributed, or labeled by MAD Beauty USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALL HANDS LYCHEE AND ASIAN PEAR MOISTURIZING HAND CLEANSING GEL WITH ALCOHOL- 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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All Hands Lychee & Asian Pear Moisturizing Hand Cleansing Gel with Alcohol

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, CI 17200(D&C Red 33), CI 42090(FD&C Blue 1).

Questions or Comments

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

Package Labeling:

ALL HANDS LYCHEE AND ASIAN PEAR MOISTURIZING HAND CLEANSING GEL WITH ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78789-048
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78789-048-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2020	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/30/2020	12/31/2024

Labeler - MAD Beauty USA LLC (117508758)

Revised: 12/2021

Document Id: d2bd8825-c161-e7ff-e053-2a95a90a3c1c

34390-5

Set id: b1cd758a-4711-33aa-e053-2995a90a0f3d

Version: 2

Effective Time: 20211209