NATURIUM SULFUR SPOT TREATMENT 8%- sulfur liquid

Naturium Sulfur Spot Treatment 8% by

Drug Labeling and Warnings

Naturium Sulfur Spot Treatment 8% by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Sulfur 8.0%

Purpose

Acne treatment

Uses

• Helps clear up acne blemishes and helps prevent new acne blemishes from forming.

Warnings

For external use only.

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• apply only to areas with acne
• Avoid eye area. In case of eye contact, flush gently and thoroughly with water.

Do not use on

• broken skin
• large areas of the skin

Keep out of reach of children.

Directions

Shake Well

• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and ask a doctor.

Other Information

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.

Inactive Ingredients

Aqua (Water), Kaolin, Aluminum Starch Octenylsuccinate, Propanediol, Glyceryl Stearate, Niacinamide, Acacia Senegal Gum, Cetearyl Alcohol, Glycerin, Ganoderma Lucidum Extract, Acetyl Glucosamine, Aloe Barbadensis Leaf Juice, Tranexamic Acid, Citric Acid, Xanthan Gum, Phenoxyethanol, Tocopheryl Acetate, Ethylhexylglycerin, 1,2-Hexanediol, Caprylyl Glycol, Potassium Sorbate, Sodium Benzoate, Tocopherol.

Product Packaging

INGREDIENTS AND APPEARANCE

NATURIUM SULFUR SPOT TREATMENT 8% 
sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPANEDIOL (UNII: 5965N8W85T)
NIACINAMIDE (UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TOCOPHEROL (UNII: R0ZB2556P8)
ACACIA (UNII: 5C5403N26O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
GANODERMA LUCIDUM WHOLE (UNII: J5P04QW0CF)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
TRANEXAMIC ACID (UNII: 6T84R30KC1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-120-01	1 in 1 CARTON	06/17/2022
1		15 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 Drug	M006	06/17/2022

Labeler - e.l.f. Cosmetics, Inc (093902816)