AcneFree Dermatology Inspired Care Acne Clearing Mask by L'Oreal USA Products Inc / Universal Packaging Systems, Inc. Drug Facts

AcneFree Dermatology Inspired Care Acne Clearing Mask by

Drug Labeling and Warnings

AcneFree Dermatology Inspired Care Acne Clearing Mask by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Universal Packaging Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACNEFREE DERMATOLOGY INSPIRED CARE ACNE CLEARING MASK- sulfur cream 
L'Oreal USA Products Inc

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.

----------

Drug Facts

Active ingredient

Sulfur 3.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use on

  • broken skin
  • large areas of the body

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 area with acne

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
  • if you experience a tightening and cooling effect that you find too strong, 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, hydroxypropryl methylcellulose, kaolin, magnesium aluminum silicate, magnesium aspartate, magnesium stearate, mannitol, menthyl lactate, methylisothiazolinone, phenoxyethanol, sodium ascorbyl phosphate, sodium cocoyl isethionate, spirea ulmaria extract, tetrasodium EDTA, titanium dioxide, ultramarines, water, zinc gluconate, zinc PCA

Questions or comments?

1-888-768-2913

image of a label

ACNEFREE DERMATOLOGY INSPIRED CARE ACNE CLEARING MASK 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49967-722
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR35 mg  in 1 mL
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)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
WATER (UNII: 059QF0KO0R)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49967-722-011 in 1 CARTON01/01/202008/31/2021
148 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/202008/31/2021
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Universal Packaging Systems, Inc.177711082MANUFACTURE(49967-722)

Revised: 7/2021