ACNEFREE THERAPEUTIC SULFUR MASK- sulfur cream 
Bausch Health US, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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 is a registered trademark of Valeant Pharmaceuticals
International, Inc., or its affiliates.

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)

AcneFree Therapeutic Sulfur Mask - 1.7 oz Carton
ACNEFREE THERAPEUTIC SULFUR MASK 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-1619
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR35 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
BENTONITE (UNII: A3N5ZCN45C)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
COPPER GLUCONATE (UNII: RV823G6G67)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYPROMELLOSE, UNSPECIFIED (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-1619-021 in 1 CARTON09/09/201408/01/2017
148 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/09/201408/01/2017
Labeler - Bausch Health US, LLC (831922468)

Revised: 5/2021
 
Bausch Health US, LLC