CANDYLAND HAND SANITIZER CL 200- alcohol gel
Gold Orient International Limited

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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CandyLand(CL 200)Hand Sanitizer

Active ingredient

Alcohol Denat. 62%

Purpose

Antiseptic

Use

Use for hand-washing to decrease bacteria on the skin, only when water is not available.

Warnings

For external use only.

Flammable, keep away from fire and flames.

When using this product

do not get into eyes.
if contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation and redness develop

Keep out of reach of children

If swallowed, get medical help or contact a Posion Control Center right away.

Directions

wet hands thoroughly with product and allow to dry with wiping

Other information

Store at 68 to 77F (20-25C)
Do not store above 110F (43C)
You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536

Inactive ingredients

Water

Glycerin,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Fragrance,

Polysorbate 20,

Sodium Hydroxide,

Red 40

Label

CANDYLAND HAND SANITIZER CL 200
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51522-019
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51522-019-01	1 in 1 POUCH	07/16/2020
1		89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/16/2020

Labeler - Gold Orient International Limited (679905914)

Name	Address	ID/FEI	Business Operations
Establishment
Gold Orient International Limited		679905914	manufacture(51522-019)