MY LITTLE PONY COTTON CANDY SCENTED- benzalkonium chloride gel
Foshan Jinxiong Technology Co ., Ltd.

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

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Use

To decrease bacteria on the skin that could cause disease

Directions

Rub a dime sized drop into hands.
For children under 6 use under adult supervision.

Warnings

For external use only - hands.
Keep out of eyes. Avoid contact with broken skin.
Stop use and ask a doctor if irritation or redness develops.
Do not inhale or ingest. If swallowed, get medical help or contact a poison control center right away.

keep out of reach of children

Inactive ingredients

water, glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, sodium hydroxide, PEG-40 hydrogenated castor oil, fragrance, may contain: red 40, red 33, blue 1, yellow 5.

text

MY LITTLE PONY COTTON CANDY SCENTED
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69795-026
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCETH-7 (UNII: 58Y261JLH5)
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69795-026-01	59 g in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/22/2017

Labeler - Foshan Jinxiong Technology Co ., Ltd. (544328419)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Jinxiong Technology Co ., Ltd.		544328419	manufacture(69795-026)