SPAI-SONS CALENDULA/MARIGOLD- calendula officinalis flower extract cream

Spai-Sons by

Drug Labeling and Warnings

Spai-Sons by is a Otc medication manufactured, distributed, or labeled by SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SPAI-SONS MARIGOLD CREAM IS BASED IN CALENDULA OFFICINALIS EXTRACT

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

THIS PRODUCT KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

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

WARNINGS

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

IMAGE OF THE CARTON LABEL

INGREDIENTS AND APPEARANCE

SPAI-SONS  CALENDULA/MARIGOLD
calendula officinalis flower extract cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66854-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	20 g  in 100 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	0.11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	brown (LIGTH BROWN)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66854-001-01	9 g in 1 JAR
2	NDC: 66854-001-03	1 in 1 BOX
2	NDC: 66854-001-02	33 g in 1 JAR
3	NDC: 66854-001-05	1 in 1 BOX
3	NDC: 66854-001-04	60 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/01/2004

Labeler - SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Registrant - SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)