END-ITCH FOR ECZEMA- end-itch for eczema cream 
Crystal Connections, LLC

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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END-ITCH FOR ECZEMA

OTC - ACTIVE INGREDIENT

Colloidal Oatmeal 37.5%

INACTIVE INGREDIENTS

Almond Oil. Beeswax, Jojoba Oil, Lanolin,
Rosemary, Vitamin E Oil

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact
a poison control center immediately.

WARNINGS

For external use only
Do not use on open cuts
When using this product do not get into eyes
Do not ingest

OTC - PURPOSE SECTION

Temporarily relieves itching from eczema.

OTC - STOP USE SECTION

Condition worsens
Sensitivity develops or increases
Symptoms last more than 7 days or
clear up and occur again in a few days

INDICATIONS & USAGE

Temporarily relieves itching from eczema.

DOSAGE & ADMINISTRATION

Apply to affected area
Rub in circular motion
Apply as needed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

End Itch Eczema.jpg

END-ITCH FOR ECZEMA 
end-itch for eczema cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60858-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.24 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALMOND OIL (UNII: 66YXD4DKO9)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
JOJOBA OIL (UNII: 724GKU717M)  
lanolin (UNII: 7EV65EAW6H)  
rosemary (UNII: IJ67X351P9)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60858-315-0394 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/15/2015
Labeler - Crystal Connections, LLC (016582119)
Establishment
NameAddressID/FEIBusiness Operations
American Pharmaceuticals and Cosmetics, Inc.038023805manufacture(60858-315)

Revised: 5/2015
Document Id: b757f29d-e7cd-4694-b5f5-5763c68f27a8
Set id: ebcf9b87-cc73-4dfb-a089-2d84dbb74e51
Version: 1
Effective Time: 20150515
 
Crystal Connections, LLC