MY LITTLE PONY(MLP 103)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.

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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 heat or flame

Do not use

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

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

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

Label Artwork

MY LITTLE PONY(MLP 103)HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51522-029
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 COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51522-029-01	1 in 1 POUCH	03/30/2020
1		30 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	03/30/2020

Labeler - Gold Orient International Limited (679905914)

Name	Address	ID/FEI	Business Operations
Establishment
Gold Orient International Limited		679905914	manufacture(51522-029)