CRAZY CLEAN HAND SANITIZER - BERRY SWIRL- alcohol liquid 
WeCool Toys, 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

Other information

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer

Ascorbyl palmitate

Celluose

Deionized Water
Fragrance - Blueberry
Glycerin
Hydroxypropyl methylcellulose
Jojoba esters
Lactose
Tocopheryl acetate
Triethanolamine
Ultramarines (CI 77007)

Package Label - Principal Display Panel

975 mL NDC: 77006-013

RNewLabel

CRAZY CLEAN HAND SANITIZER - BERRY SWIRL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-013
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)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77006-013-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:77006-013-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:77006-013-02249 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
4NDC:77006-013-04975 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - WeCool Toys, Inc. (080480202)
Registrant - WeCool Toys, Inc. (080480202)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775manufacture(77006-013) , label(77006-013) , pack(77006-013)

Revised: 1/2022
Document Id: d5660475-f5c5-c05b-e053-2995a90a6fd4
Set id: a6a6b2ae-6fb8-7793-e053-2995a90a2a69
Version: 5
Effective Time: 20220112
 
WeCool Toys, Inc.