NDC 0187-1619 Acnefree Therapeutic Sulfur Mask

NDC Product Code 0187-1619

NDC 0187-1619-02

Package Description: 1 TUBE in 1 CARTON > 48 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Acnefree Therapeutic Sulfur Mask with NDC 0187-1619 is a product labeled by Valeant Pharmaceuticals North America Llc. The generic name of Acnefree Therapeutic Sulfur Mask is . The product's dosage form is and is administered via form.

Labeler Name: Valeant Pharmaceuticals North America Llc

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Valeant Pharmaceuticals North America Llc
Labeler Code: 0187
Start Marketing Date: 09-09-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Acnefree Therapeutic Sulfur Mask Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

* Please review the disclaimer below.