WE CLEAN HAND SANITIZER ROASTED MARSHMALLOW- alcohol liquid 
WeCool Toys

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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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

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

Other information

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL58.36 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77006-031-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/26/2020
Labeler - WeCool Toys (080480202)
Registrant - WeCool Toys (080480202)
Establishment
NameAddressID/FEIBusiness Operations
Landy545291775manufacture(77006-031) , label(77006-031) , pack(77006-031)

Revised: 1/2022
Document Id: d567d693-9dfc-f51a-e053-2995a90a304b
Set id: aa9124aa-2dd9-780b-e053-2a95a90a659d
Version: 2
Effective Time: 20220112
 
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