WECLEAN HAND SANITIZER GEL - EUCALYPTUS- alcohol liquid 
WeCoolToys, Inc.

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

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer

Ascorbyl palmitate

Celluose

Deionized Water

Glycerin

Fragrance - Eucalyptus & Mint

Hydroxypropyl methylcellulose

Jojoba esters

Limonene
Linalool

Lactose

Tocopheryl acetate

Triethanolamine
Ultramarines (CI 77007)

Other information

Package Label - Principal Display Panel

1000 mL NDC: 77006-001

Label

WECLEAN HAND SANITIZER GEL - EUCALYPTUS 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-001
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
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77006-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
2NDC:77006-001-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
3NDC:77006-001-03248.4 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/08/2020
4NDC:77006-001-041010 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/08/2020
Labeler - WeCoolToys, Inc. (080480202)
Registrant - WeCool Toys, Inc. (080480202)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(77006-001) , pack(77006-001) , label(77006-001)

Revised: 1/2022
Document Id: d5680ca0-cd0a-b448-e053-2a95a90ac4a2
Set id: a5a2bd78-b302-eff2-e053-2995a90ad296
Version: 2
Effective Time: 20220112
 
WeCoolToys, Inc.