END-ITCH FOR SUNBURN- end-itch for sunburn 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 SUNBURN

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 discomfort of sunburn.

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 12% Skin Protectant

INACTIVE INGREDIENT SECTION

Almond Oil, Beeswax, Grapefruit, Jojoba Oil,

Lanolin, Peppermint, Vitamin E Oil

INDICATIONS & USAGE SECTION

Temporarily relieves itching from sunburn.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep Out Of Reach Of Children.
If swallowed get medical help or contact
a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Apply to affected area
Rub in circular motion
Apply as needed

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

End Itch Sunburn.jpgEnd Itch Sunburn.jpg

END-ITCH FOR SUNBURN 
end-itch for sunburn cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60858-316
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
oatmeal (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) oatmeal11.62 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALMOND OIL (UNII: 66YXD4DKO9)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
GRAPEFRUIT (UNII: O82C39RR8C)  
JOJOBA OIL (UNII: 724GKU717M)  
LANOLIN (UNII: 7EV65EAW6H)  
PEPPERMINT (UNII: V95R5KMY2B)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60858-316-0390.71 g in 1 BOTTLE; Type 0: Not a Combination Product
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 Pharmaceutical and Cosmetics, Inc.038023805manufacture(60858-316)

Revised: 5/2015
Document Id: c1ef8771-9a7a-4d3e-9d13-4d1a9ccfe239
Set id: 76afec1a-8541-455d-bc6c-4d1932b2e3d2
Version: 1
Effective Time: 20150507
 
Crystal Connections, LLC