PLAY-DOH HAND SANITIZER (PLYD 102)- alcohol gel

Play-Doh Hand Sanitizer by

Drug Labeling and Warnings

Play-Doh Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Gold Orient International Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

1. Alcohol 62% v/v.

Purpose

Antiseptic

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 heat or flame

Do not use

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

WHEN USING

· Do not get into eyes.

· if contact occurs, rinse eyes thoroughly with water

STOP USE

irritation and redness develop

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

• wet hands thoroughly with product and allow to dry without wiping

Other information

• Store between 66 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 Acrylates Crosspolymer, Fragrance, Polysorbate 20, Sodium Hydroxide, Red 33, Blue 1

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

PLAY-DOH HAND SANITIZER  (PLYD 102)
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51522-033
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
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51522-033-01	1 in 1 POUCH	03/30/2020
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Gold Orient International Limited (679905914)

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	manufacture(51522-033)