CRAZY CLEANZ HAND SANITIZER EUCALYPTUS SCENTED- benzalkonium chloride liquid
Landy International

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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51706-954 Crazy Cleanz Hand Sanitizer Eucalyptus Scented 0.1% Benzalkonium chloride

Active Ingredient(s)

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Use

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 occurs.
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.

Inactive ingredients

Blue 1(Cl 42090), Didecyldimonium chloride,Fragrance(Parfum),Glycerin,
PEG-40 hydrogenated castor oil, Polyaminopropyl biguanide,
Water(Aqua),Yellow 5(C119140).

Package Label - Principal Display Panel

CRAZY CLEANZ HAND SANITIZER EUCALYPTUS SCENTED
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-954
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51706-954-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/15/2020

Labeler - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(51706-954)