PLAY-DOH HAND SANITIZER- 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.

----------

Active Ingredient(s)

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 fire or flames

Do not use

Do not get into eyes.

if contact occurs, rinse eyes thoroughly with water


irritation and redness develop

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

Inactive ingredients

Water, Glycerin, Acrylates/ C10-30 Alkyl Acrylates Crosspolymer, Fragrance, Polysorbate 20, Sodium Hydroxide, Red 33

Package Label - Principal Display Panel

label

PLAY-DOH HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51522-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51522-016-011 in 1 POUCH03/30/2020
189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Gold Orient International Limited (679905914)
Establishment
NameAddressID/FEIBusiness Operations
Gold Orient International Limited679905914manufacture(51522-016)

Revised: 7/2020
Document Id: aa702630-5890-24d3-e053-2995a90a8b22
Set id: aa701996-f354-49f6-e053-2a95a90a6cbf
Version: 1
Effective Time: 20200714
 
Gold Orient International Limited