WECLEAN HAND SANITIZER PUMPKIN SWIRL- 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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Alcohol 62% v/v. Purpose: Antiseptic

Antiseptic, Hand Sanitizer

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

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

· 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.

· 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.

· Store between 15-30C (59-86F)

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

Acrylates/C10-30 alkyl acrylate crosspolymer

Ascorbyl palmitate

Butylphenyl methylpropional
Celluose

Citronellol

Coumarin

Deionized waterGeraniol

Fragrance - Pumpkin swirl scent

GlycerinHexyl cinnamal

Hydroxycitronellal

Hydroxypropyl methylcellulose
Jojoba esters
Lactose
Limonene
LinaloolRed 4 (CI 14700)

Tocopheryl acetate
Triethanolamine

Yellow 5 (CI 19140)


NDC 77006-030

Label

WECLEAN HAND SANITIZER PUMPKIN SWIRL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-030
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
TROLAMINE (UNII: 9O3K93S3TK)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
.BETA.-CITRONELLOL, (S)- (UNII: 8RSY5Y5658)  
GERANIOL (UNII: L837108USY)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
COUMARIN (UNII: A4VZ22K1WT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77006-030-01250 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(77006-030) , pack(77006-030) , label(77006-030)

Revised: 1/2022
Document Id: d567f782-84a1-178f-e053-2995a90ad2e8
Set id: aa8fb91a-0b39-130e-e053-2995a90a7f97
Version: 2
Effective Time: 20220112
 
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