POWERSPOT CLEANSE- sulfur soap

PowerSpot Cleanse by

Drug Labeling and Warnings

PowerSpot Cleanse by is a Otc medication manufactured, distributed, or labeled by Bluemercury. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Sulfur 3%

Purpose

Acne treatment

Uses

• For the treatment of acne
• Helps keep skin clear of new acne blemishes

Warnings

For external use only.

• Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.
• 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.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Gently lather a small amount of cleanser in moistened hands and apply to face and neck. Rinse with warm water.

Inactive Ingredients

Water (Aqua), Sodium Cocoyl Isethionate, Cetearyl Alcohol, Coco-Glucoside, Colloidal Sulfur, Isoamyl Laurate, Coconut Alcohol, Xanthan Gum, Salicylic Acid, Glycolic Acid, Camphor, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Curcuma Longa (Tumeric) Root Extract, Ocimum Basilicum (Basil) Extract, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Extract, Melia Azadirachta Flower Extract, Lawsonia Inermis (Henna) Extract, Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant) Fruit Extract, Melia Azadirachta Leaf Extract, Ocimum Sanctum Leaf Extract, Amino Esters-1, Glycerin, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Acrylates Copolymer, Malachite Extract, Mica, Pearl Powder

PRINCIPAL DISPLAY PANEL - 120 mL Tube Carton

m-61®
powerful skincare

PowerSpot
Cleanse

CLARIFYING
3% SULFUR
ACNE TREATMENT
FACE CLEANSER

Blemish-fighting
and clarifying
foaming cleanser
with salicylic acid,
tea tree & cucumber

combination / blemish-prone skin

100% paraben-free
100% synthetic fragrance-free
dermatologist tested
allergy tested

120 mL e 4 FL. OZ.

INGREDIENTS AND APPEARANCE

POWERSPOT CLEANSE 
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72203-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
XANTHAN GUM (UNII: TTV12P4NEE)
SALICYLIC ACID (UNII: O414PZ4LPZ)
GLYCOLIC ACID (UNII: 0WT12SX38S)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
TEA TREE OIL (UNII: VIF565UC2G)
TURMERIC (UNII: 856YO1Z64F)
BASIL (UNII: 2U0KZP0FDW)
RICE BRAN (UNII: R60QEP13IC)
OAT (UNII: Z6J799EAJK)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
LAWSONIA INERMIS LEAF (UNII: E5818YZ355)
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
EGGPLANT (UNII: W5K7RAS4VK)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
HOLY BASIL LEAF (UNII: SCJ765569P)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
MICA (UNII: V8A1AW0880)
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72203-014-01	1 in 1 CARTON	03/15/2019
1		120 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72203-014-02	1 in 1 CARTON	03/15/2019
2		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	03/15/2019

Labeler - Bluemercury (097435361)