SPAI-SONS MARIGOLD OILY SKIN- sulfur 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

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

PURPOSE

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

Keep out of reach of children

INDICATIONS & USAGE

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.

WARNINGS

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL

INGREDIENTS AND APPEARANCE

SPAI-SONS   MARIGOLD OILY SKIN
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66854-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	0.1 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66854-023-01	9 g in 1 JAR
2	NDC: 66854-023-02	33 g in 1 JAR
3	NDC: 66854-023-03	60 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/30/2012

Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Establishment
Name	Address	ID/FEI	Business Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS		880172184	analysis, label, manufacture, pack