HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Landy International, Wecool Toys. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 62%

Purpose

Antiseptic

Use

helps eliminate bacteria on hands

Warnings

For external use only.
Flammable, Keep away from heat or flame,
Do not use
On children less than 2 months of age. on open skin wounds
When using this product keep out of eyes, ear, and mouth.
In case of contact with eve, 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

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

Acrylates(C10-30 acrylate crosspolymer, Ascorbyl palmitate, Blue 1 (CI42090),
Celluulose, Coumarin, Fagrance (Parfum), Glycein, Hydroxypropvl methylcellulose, Jojoba
Esters, lactose, Limonene, Linalool, Red 33( CI17200), Tocopheryl acetate,
Triethanolamine, Ultramarines (CI77007), Water(Aqua).

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51706-913
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COUMARIN (UNII: A4VZ22K1WT)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TROLAMINE (UNII: 9O3K93S3TK)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ULTRAMARINE BLUE (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51706-913-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
2	NDC: 51706-913-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
3	NDC: 51706-913-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2020

Labeler - Landy International (545291775)

Registrant - Landy International (545291775)

Establishment
Name	Address	ID/FEI	Business Operations
Wecool Toys		080480202	label(51706-913)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture(51706-913)