KORIUM WOUND CARE- calendula officinalis 1x hpus spray 
GR8BIO LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Korium

Calendula Officinalis 1X HPUS -2%

Healing Agent

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

FOR EXTERNAL USE ONLY

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

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 AND ASK DOCTOR IF YOU:

Have any allergic reaction to this product.

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

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

DIRECTIONS

OTHER INFORMATION

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

Do not use if tamper evident seal is broken.

Butylated Hydroxytoluene

Ethanol

Polyethylene Glycol

Purified Water

LABEL

KORIUM  WOUND CARE
calendula officinalis 1x hpus spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70811-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE1 [hp_X]  in 20 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALCOHOL (UNII: 3K9958V90M)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70811-001-0020 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/20/2016
Labeler - GR8BIO LLC (080291999)
Registrant - Homeocare Laboratories Inc. (088248828)
Establishment
NameAddressID/FEIBusiness Operations
Homeocare Laboratories Inc.088248828manufacture(70811-001)

Revised: 1/2020
Document Id: 9ce84ac9-0aaa-1f5f-e053-2a95a90a8456
Set id: 441eb19f-4280-01b7-e054-00144ff8d46c
Version: 2
Effective Time: 20200124
 
GR8BIO LLC