ACNE TREATMENT SULFUR WASH RODAN AND FIELD- sulfur liquid

Acne Treatment Sulfur Wash by

Drug Labeling and Warnings

Acne Treatment Sulfur Wash by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields, LLC. , Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient      Purpose

Sulfur 3%                Acne treatment

Uses

For the treatment of acne

Helps keep skin clear of new acne, blemishes, pimples, and blackheads.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Do not use on Broken skin or apply to large areas of the body

for external use only.

using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin, if this occurs, only one medication should be used unless directed by a doctor.

do not get into eyes, if excessive skin irritation develops or increases, discontinue use and consult a doctor.

apply to affected areas only.

wet skin with lukewarm water. Using fingertips, gently and evenly massage a quarter-sized amount onto entire face for 30-60 seconds, avoid contact with eyes.

Rinse thoroughly; pat dry. use once daily and increase to twice daily as tolerated.

Water, Sodium Laureth Sulfate, Distearyl Phthalic Acid Amide, Lauryl Glucoside, Hydrogenated Polyisobutene, Dissodecyl Adipate, Glycerin, Cetearyl Alcohol, Acacia Senegal Gum, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, Cetyl Alcohol, Ceteareth-20, Magnesium Aluminum Silicate, Fragrance, C13-14 Isoparaffin, Bisabolol, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Xanthan Gum, Aloe Barnadensis Leaf Juice, Laureth-7, Camellia Oleifera Leaf Extract, Arnica Montana Flower Extrat, Blue 1, Violet 2, Titanium Dioxide, Red 33

PRINCIPAL DISPLAY PANEL

Rodan and Fields

Unblemish

Dermatologist Developed Acne Treatment

Sulfur Wash

125 mL/ 4.2 Fl. Oz.

INGREDIENTS AND APPEARANCE

ACNE TREATMENT SULFUR WASH  RODAN AND FIELD
sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ACACIA (UNII: 5C5403N26O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LEVOMENOL (UNII: 24WE03BX2T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAURETH-7 (UNII: Z95S6G8201)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2050-2	1 in 1 CARTON
1	NDC: 14222-2050-1	125 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/08/2011

Labeler - Rodan & Fields, LLC. (051659584)

Registrant - Cosmetic Enterprises Ltd (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd		017701475	manufacture(14222-2050)