SPAI-SONS CALENDULA/MARIGOLD- calendula officinalis flower extract cream 
SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS

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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SPAI-SONS MARIGOLD CREAM / CREMA DE CALENDULA

SPAI-SONS MARIGOLD CREAM IS BASED IN CALENDULA OFFICINALIS EXTRACT

THE PRODUCT HAS BEEN DEVELOPED TO IMPLEMENT IN AREAS WHERE THIS FLASH, USEFUL IN WOUND HEALING PROCESS

THIS PRODUCT KEEP OUT OF REACH OF THE CHILDREN

THIS PRODUCTT MAY BE USED IN PEOPLE WHO DO NOT SUBMIT HYPERSENSITIVITY COMPONENTS, CAN BE USED AS A DAILY MOISTURIZING SKIN

AVOID IN TAKE OF PRODUCT, IF SO CHECK WITH YOUR DOCTOR

THE PRODUCT IS TOPICAL APPLICATION, APPLY THE AMOUNT NEEDED IN THE AREA DESIRED

THE EXCIPIENTS CONTAINED IN THIS PRODCUT ARE PART OF A FORMULATION BASE ON A MOISTURIZER AND CONDITIONING THE SKIN, WHICH DOES NOT GENERATE IRRITATION, SO ITS USE IS NOT CONTRAINDICATED.
ALSO CALENDULA OFFICINALIS EXTRACT HAS OTHER NATURAL EXTRACTS THAT HELP GIVE A BETTER FEELING IN THE SKIN.

IMAGE OF THE CARTON LABELIMAGE OF THE CARTON LABEL

SPAI-SONS  CALENDULA/MARIGOLD
calendula officinalis flower extract cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER20 g  in 100 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LACTIC ACID (UNII: 33X04XA5AT)  
DEXTROSE (UNII: IY9XDZ35W2)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CHAMOMILE (UNII: FGL3685T2X)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Colorbrown (LIGTH BROWN) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66854-001-019 g in 1 JAR
2NDC:66854-001-031 in 1 BOX
2NDC:66854-001-0233 g in 1 JAR
3NDC:66854-001-051 in 1 BOX
3NDC:66854-001-0460 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/01/2004
Labeler - SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Registrant - SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Revised: 4/2012
Document Id: d5e0b1f7-aecb-40d6-b2ea-41257b43cc5f
Set id: 92f6d96f-d7cd-4588-ae02-b86ca984e23e
Version: 1
Effective Time: 20120425
 
SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS