My Little Pony Cotton Candy Scented: Package Insert and Label Information

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.

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
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
POLYOXYL 40 HYDROGENATED CASTOR OIL
D&C RED NO. 33
FD&C RED NO. 40
WATER
GLYCERIN
COCETH-7
PPG-1-PEG-9 LAURYL GLYCOL ETHER
SODIUM HYDROXIDE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Product Characteristics
Color Score
Shape Size
Flavor COTTON CANDY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69795-026-01 59 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 08/22/2017
Labeler — Foshan Jinxiong Technology Co ., Ltd. (544328419)
Establishment
Name Address ID/FEI Operations
Foshan Jinxiong Technology Co ., Ltd. 544328419 manufacture (69795-026)

Revised: 08/2017 Foshan Jinxiong Technology Co ., Ltd.

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