WECLEAN HAND SANITIZER PUMPKIN SWIRL- alcohol liquid

WeClean Hand Sanitizer Pumpkin Swirl by

Drug Labeling and Warnings

WeClean Hand Sanitizer Pumpkin Swirl by is a Otc medication manufactured, distributed, or labeled by WeCool Toys, Landy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 62% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

· 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.

STORAGE AND HANDLING

· Store between 15-30C (59-86F)

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

INACTIVE INGREDIENT

Acrylates/C10-30 alkyl acrylate crosspolymer

Ascorbyl palmitate

Butylphenyl methylpropional
Celluose

Citronellol

Coumarin

Deionized waterGeraniol

Fragrance - Pumpkin swirl scent

GlycerinHexyl cinnamal

Hydroxycitronellal

Hydroxypropyl methylcellulose
Jojoba esters
Lactose
Limonene
LinaloolRed 4 (CI 14700)

Tocopheryl acetate
Triethanolamine

Yellow 5 (CI 19140)

PRINCIPAL DISPLAY PANEL

NDC: 77006-030

INGREDIENTS AND APPEARANCE

WECLEAN HAND SANITIZER PUMPKIN SWIRL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77006-030
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.BETA.-CITRONELLOL, (S)- (UNII: 8RSY5Y5658)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
COUMARIN (UNII: A4VZ22K1WT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77006-030-01	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/26/2020

Labeler - WeCool Toys (080480202)

Registrant - WeCool Toys (080480202)

Establishment
Name	Address	ID/FEI	Business Operations
Landy		545291775	manufacture(77006-030) , pack(77006-030) , label(77006-030)