WECLEAN FOAM HAND SANITIZER EUCALYPTUS- benzalkonium chloride liquid

WeClean Foam Hand Sanitizer Eucalyptus by

Drug Labeling and Warnings

WeClean Foam Hand Sanitizer Eucalyptus by is a Otc medication manufactured, distributed, or labeled by WeCool Toys, Inc., Landy International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium chloride: 0.20% 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.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

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

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

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

PEG-40 hydrogenated castor oil

Polyaminopropyl biguanide

Package Label - Principal Display Panel

NDC: 77006-002

INGREDIENTS AND APPEARANCE

WECLEAN FOAM HAND SANITIZER EUCALYPTUS 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77006-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	200 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-50 HYDROGENATED CASTOR OIL (UNII: R07D3A9614)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)
DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77006-002-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 77006-002-02	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/30/2020

Labeler - WeCool Toys, Inc. (080480202)

Registrant - WeCool Toys, Inc. (080480202)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture(77006-002) , label(77006-002) , pack(77006-002)