END-ITCH FOR SUNBURN cream

END-ITCH FOR SUNBURN by

Drug Labeling and Warnings

END-ITCH FOR SUNBURN by is a Otc medication manufactured, distributed, or labeled by Crystal Connections, LLC, American Pharmaceutical and Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.jpg

INGREDIENTS AND APPEARANCE

END-ITCH FOR SUNBURN 
end-itch for sunburn cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60858-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
oatmeal (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	oatmeal	11.62 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60858-316-03	90.71 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/15/2015

Labeler - Crystal Connections, LLC (016582119)

Establishment
Name	Address	ID/FEI	Business Operations
American Pharmaceutical and Cosmetics, Inc.		038023805	manufacture(60858-316)