WECLEAN HAND SANITIZER - ORANGE APPLE SCENT- 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)

Alcoho 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
Celluose
Fragrance - Orange Apple scent

Hydroxypropyl methylcellulose
Glycerin

Jojoba esters
Lactose

Red 4 (CI 14700)

Tocopheryl acetate

Triethanolamine

Water

Yellow 5 (CI 19140)

Package Label - Principal Display Panel

249 mL NDC: 77006-061-01

label

WECLEAN HAND SANITIZER - ORANGE APPLE SCENT 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-061
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)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)  
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77006-061-01249 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/11/2020
Labeler - WeCool Toys (080480202)
Registrant - WeCool Toys (080480202)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(77006-061)

Revised: 1/2022
Document Id: d567d005-edca-3c62-e053-2995a90ac042
Set id: af14b044-cc68-2bc7-e053-2995a90ab14e
Version: 4
Effective Time: 20220112
 
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