CRAZY CLEANZ FOAMING HAND SANITIZER - EUCALYPTUS- benzalkonium chloride 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) Purpose

Benzalkonium Chloride 0.10%..................Antiseptic

Use(s): Helps eliminate bacteria on hands.

WARNINGS: For external use only

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 thouroughly with water.

STOP USE AND ASK A DOCTOR if irritation or rash occures. These may be a sign of a serious condition.

KEEP OUT OF REACH OF CHILDREN,

except under adult supervision. 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 (56-86F)

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

Inactive Ingredients:

Deionized water
Glycerin
Didecyldimonium chloride
FD&C Blue 1
FD&C Yellow 5
Fragrance - Eucalyptus
Limonene
Linalool

PEG-40 hydrogenated castor oil

Polyaminopropyl biguanide

NDC 77006-010

RNLabel

CRAZY CLEANZ FOAMING HAND SANITIZER - EUCALYPTUS 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE200 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
POLYOXYL 50 HYDROGENATED CASTOR OIL (UNII: R07D3A9614)  
DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)  
WATER (UNII: 059QF0KO0R)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77006-010-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/18/2020
2NDC:77006-010-02250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/18/2020
Labeler - WeCool Toys, Inc. (080480202)
Registrant - WeCool Toys, Inc. (080480202)
Establishment
NameAddressID/FEIBusiness Operations
Landy International545291775label(77006-010) , manufacture(77006-010) , pack(77006-010)

Revised: 1/2022
Document Id: d567dd4d-e402-12ab-e053-2995a90aaf19
Set id: a6a7683a-cefc-cefd-e053-2995a90a9cb5
Version: 3
Effective Time: 20220112
 
WeCool Toys, Inc.