We Clean Hand Sanitizer Roasted Marshmallow by WeCool Toys / Landy

Drug Details [pdf]

WE CLEAN HAND SANITIZER ROASTED MARSHMALLOW- alcohol liquid
WeCool Toys

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Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer

Ascorbyl palmitate

Benzyl salicylate

Blue 1 (CI 42090)

Celluose

Coumarin

Deionized water

Fragrance - Roasted Marshmallow

Glycerin

Hydroxypropyl methylcellulose

Jojoba esters

Lactose

Red 33 (CI 17200)

Tocopheryl acetate

Triethanolamine

Yellow 5 (CI 19140)

Package Label - Principal Display Panel

250 mL NDC: 770006-031-01

Label

WE CLEAN HAND SANITIZER ROASTED MARSHMALLOW
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77006-031
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	58.36 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ASCORBYL PALMITATE (UNII: QN83US2B0N)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TROLAMINE (UNII: 9O3K93S3TK)
DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COUMARIN (UNII: A4VZ22K1WT)
WATER (UNII: 059QF0KO0R)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 77006-031-01	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/26/2020	02/01/2025

Labeler - WeCool Toys (080480202)

Registrant - WeCool Toys (080480202)

Name	Address	ID/FEI	Business Operations
Establishment
Landy		545291775	manufacture(77006-031) , label(77006-031) , pack(77006-031)

Revised: 2/2025

Document Id: 2d582c20-c041-3c9e-e063-6294a90adc28

Set id: aa9124aa-2dd9-780b-e053-2a95a90a659d

Version: 3

Effective Time: 20250204