WECLEAN HAND SANITIZER - ORANGE APPLE SCENT- alcohol liquid

WeClean Hand Sanitizer - Orange Apple Scent by

Drug Labeling and Warnings

WeClean Hand Sanitizer - Orange Apple Scent by is a Otc medication manufactured, distributed, or labeled by WeCool Toys, Landy International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcoho 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

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

Acrylates/C10-30 alkyl acrylate crosspolymer

Ascorbyl palmitate
Celluose
Fragrance - Orange Apple scent

Hydroxypropyl methylcellulose
Glycerin

Jojoba esters
Lactose

Red 4 (CI 14700)

Tocopheryl acetate

Triethanolamine

Water

Yellow 5 (CI 19140)

Package Label - Principal Display Panel

249 mL NDC: 77006-061-01

INGREDIENTS AND APPEARANCE

WECLEAN HAND SANITIZER - ORANGE APPLE SCENT 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77006-061
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
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77006-061-01	249 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/11/2020

Labeler - WeCool Toys (080480202)

Registrant - WeCool Toys (080480202)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture(77006-061)