SHOPKINS HAND SANITIZER- chloroxylenol liquid 
Ashtel Studios, Inc.

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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Shopkins HAND SANITIZER

Drug Facts

Active Ingredient

CHLOROXYLENOL 0.05%

Purpose

Antiseptic

Use

To help reduce bacteria and germs on the skin.

Warning

Flammable. Keep away from fire or flame. For external use only
• Stop use and ask a doctor if irritation or redness develops and persists.

• Keep out of reach of children. In case of accidental digestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• Place enough product in palm to cover hands and rub hands together briskly until dry. • Children under 6, use only under adult supervision.   • Not recommended for infants.

Inactive Ingredients

Aqua, Propylene Glycol, Phenoxyethanol, Coceth-7, Ppg-1-peg-9 Lauryl Glycol Ether, Peg-40 Hydrogenated Castor Oil, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Parfum, Sodium Hydroxide.

Other Information

• Do not store above 100° F (38° C). • May discolor some fabrics. • Harmful to wood finishes and plastics.

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Packaging

image description

SHOPKINS HAND SANITIZER 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCETH-7 (UNII: 58Y261JLH5)  
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70108-010-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/16/2017
Labeler - Ashtel Studios, Inc. (148689180)

Revised: 12/2019
Document Id: e4f02a04-dcc2-4f7f-a04e-7c6322f22a3b
Set id: 0506ca7d-b54b-48bc-ac3a-159e6816109f
Version: 2
Effective Time: 20191231
 
Ashtel Studios, Inc.