CRAZY CLEAN HAND SANITIZER - BLUE RASPBERRY- 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

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.

Directions

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.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer

Ascorbyl palmitate

Celluose

Deionized Water
Ethanol (≥95%)

FD&C Red 33(CI 17200)
FD&C Blue 1(CI 42090)
Fragrance - Blueberry

Glycerin
Hydroxypropyl methylcellulose
Jojoba esters

Lactose
Tocopheryl acetate

Triethanolamine
Ultramarines (CI 77007)

Package Label - Principal Display Panel

250 mL NDC: 77006-012

Label

CRAZY CLEAN HAND SANITIZER - BLUE RASPBERRY
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77006-012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	58.36 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ULTRAMARINE BLUE (UNII: I39WR998BI)
DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)
TROLAMINE (UNII: 9O3K93S3TK)
DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
WATER (UNII: 059QF0KO0R)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77006-012-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:77006-012-02	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:77006-012-03	249 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
4	NDC:77006-012-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - WeCool Toys, Inc. (080480202)

Registrant - WeCool Toys, Inc. (080480202)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(77006-012) , label(77006-012) , pack(77006-012)

Revised: 6/2020

Document Id: a744bceb-1b21-6d91-e053-2a95a90ab0be

Set id: a6a6960e-6be4-59a0-e053-2a95a90a9b50

Version: 2

Effective Time: 20200604

WeCool Toys, Inc.