ACNEFREE THERAPEUTIC SULFUR MASK- sulfur cream

ACNEFREE THERAPEUTIC SULFUR MASK by

Drug Labeling and Warnings

ACNEFREE THERAPEUTIC SULFUR MASK by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Ei LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sulfur 3.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

When using this product

• Skin irritation and dryness are 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.
• Do not get into eyes.

Do Not Use on:

• broken skin
• large areas of the body

Stop use and consult a doctor

if skin irritation occurs or gets worse.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Gently massage into clean wet skin for two to three minutes until mask turns light blue for maximum absorption. Leave on for an additional 10 minutes, until dry. Rinse off with warm water and pat dry. You may experience a tightening and cooling effect. Some individuals may find the cooling feeling too strong - simply rinse off the mask immediately if uncomfortable. Use 2-3 times per week, or as desired. Avoid the eye and lip areas.

Other information

Store at 59° - 95° F (15-35° C).

Avoid product contact with silver jewelry, which may be discolored by this product.

Inactive ingredients

acacia senegal gum, bentonite, butylene glycol, cellulose, copper gluconate, ethylhexylglycerin, hydroxypropyl methylcellulose, kaolin, magnesium aluminum silicate, magnesium aspartate, magnesium stearate, mannitol, menthyl lactate, methylisothiazolinone, phenoxyethanol, sodium ascorbyl phosphate, sodium cocoyl isethionate, spiraea ulmaria extract, tetrasodium EDTA, titanium dioxide, ultramarines, water, zinc gluconate, zinc PCA

Questions or Comments?

1-800-321-4576

Distributed by: Valeant Consumer Products,

a division of Valeant Pharmaceuticals North America LLC,

Bridgewater, NJ 08807

acnefree.com

Made in USA

©2015

Rev. 01/15

9381401

Package/Label Principal Display Panel

AcneFree®

CLEAR SKIN TREATMENTS

Therapeutic

Sulfur Mask

with Vitamin C & Copper

Helps to:

• Clear Acne
• Absorb Excess Oil
• Unclog Pores

COLOR-SIGNAL

TECHNOLOGY

Changes color to signal

maximum absorption

NET WT 1.7 OZ (48 g)

INGREDIENTS AND APPEARANCE

ACNEFREE THERAPEUTIC SULFUR MASK 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1619
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	35 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
BENTONITE (UNII: A3N5ZCN45C)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
COPPER GLUCONATE (UNII: RV823G6G67)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
EDETATE SODIUM (UNII: MP1J8420LU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
ZINC PIDOLATE (UNII: C32PQ86DH4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1619-02	1 in 1 CARTON
1		48 g 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	09/09/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	MANUFACTURE(0187-1619)