SPAI-SONS  MARIGOLD OILY SKIN- sulfur 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.

----------

SPAI-SONS CREMA DE CALENDULA PIEL GRASA/ MARIGOLD CREAM OILY SKIN

Marigold extracts of medicinal plants, bio-sulfur and a selection of natural assets for the treatment of some skin rashes.

For treatment of some skin rashes that do not participate in the pathogenic microorganisms, particularly the treatment of acne.


Keep out of reach of children

Due to its composition Marigold cream is very active to normalize oily skin, hyper-secretory, body rashes, burns, or as an accelerator of wound healing, its greatest virtue is the design as an adjunct in the treatment of acne.

Avoid the contact with eyes. suspend its use if you notice an unfavorable reaction on the skin.

Apply a sufficient amount and gently spread with fingertips until the skin absorbs it. This product is for topical application

The formula includes extracts of medicinal plants and bio-sulfur, a trace element essential to cellular organization, is an asset which splits fats and regulates the secretion of the sebaceous glands, act synergistically other extracts such as healing, anti-inflamatory, antiseptic, antipuritic dermal, refreshing and soothing.

IMAGE OF THE LABEL IMAGE OF THE LABEL

SPAI-SONS   MARIGOLD OILY SKIN
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.1 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)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
LACTIC ACID (UNII: 33X04XA5AT)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 85 (UNII: A7F3N56197)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
GINGER (UNII: C5529G5JPQ)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
DIMETHICONE PEG-7 ISOSTEARATE (UNII: JVS3399FNW)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
ALLANTOIN (UNII: 344S277G0Z)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66854-023-019 g in 1 JAR
2NDC:66854-023-0233 g in 1 JAR
3NDC:66854-023-0360 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/30/2012
Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
Establishment
NameAddressID/FEIBusiness Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack

Revised: 6/2012
Document Id: c18084e3-4a9d-4622-8d28-32fc10c29656
Set id: 6c453982-23f3-4d9e-a451-d5e6ad9926ba
Version: 1
Effective Time: 20120607
 
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS