KORIUM WOUND CARE- calendula officinalis 1x hpus spray

Korium by

Drug Labeling and Warnings

Korium by is a Homeopathic medication manufactured, distributed, or labeled by GR8BIO LLC, Homeocare Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Calendula Officinalis 1X HPUS -2%

PURPOSE

Healing Agent

INDICATIONS & USAGE

May help promote healing of minor cuts, scratches and chafing.

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

DO NOT USE if you are allergic to Calendula officinalis or to any of this product's inactive ingredients.

WHEN USING

WHEN USING THIS PRODUCT:

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

You may experience some transient mild pain on the wound area.

STOP USE

STOP USE AND ASK DOCTOR IF YOU:

Have any allergic reaction to this product.

Experience a deep or puncture wound, animal bite, or serious burn.

KEEP OUT OF REACH OF CHILDREN

KWEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

DIRECTIONS

• clean affected area thoroughly before applying
• apply spray twice a day (every 12 hours) on affected area until entirely covered.
• let dry and cover with a sterile bandage to promote healing.
• continue use as needed

OTHER SAFETY INFORMATION

OTHER INFORMATION

Store at room temperature 68-77°F (20-25°C).

Do not use if tamper evident seal is broken.

INACTIVE INGREDIENT

Butylated Hydroxytoluene

Ethanol

Polyethylene Glycol

Purified Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KORIUM  WOUND CARE
calendula officinalis 1x hpus spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70811-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H)	CALENDULA OFFICINALIS WHOLE	1 [hp_X]  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70811-001-00	20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/20/2016

Labeler - GR8BIO LLC (080291999)

Registrant - Homeocare Laboratories Inc. (088248828)

Establishment
Name	Address	ID/FEI	Business Operations
Homeocare Laboratories Inc.		088248828	manufacture(70811-001)