NDC 73672-981 Acne Relief Cream

Salicylic Acid 0.5%

NDC Product Information

Acne Relief Cream with NDC 73672-981 is a a human over the counter drug product labeled by Metacan Inc Ste. The generic name of Acne Relief Cream is salicylic acid 0.5%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Metacan Inc Ste

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug 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.

Acne Relief Cream Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SALICYLIC ACID 5 mg/mL

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.

  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • OATMEAL (UNII: 8PI54V663Y)
  • ALOE (UNII: V5VD430YW9)
  • LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
  • MYELOPEROXIDASE (UNII: JQZ6YM58U5)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • HEMP (UNII: TD1MUT01Q7)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • WATER (UNII: 059QF0KO0R)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)
  • WILLOW BARK (UNII: S883J9JDYX)
  • BLACK PEPPER OIL (UNII: U17J84S19Z)
  • CLOVE OIL (UNII: 578389D6D0)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • PULLULAN (UNII: 8ZQ0AYU1TT)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • GLUCOSE OXIDASE (UNII: 0T8392U5N1)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Metacan Inc Ste
Labeler Code: 73672
FDA Application Number: part333D What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-10-2020 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: 12-31-2021 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: N 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.

Acne Relief Cream 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

Salicylic Acid 0.5%

Purpose

Salicylic Acid 0.5%..Acne Treatment

Uses

For the treatment of acne.

Warnings

For external use only

Otc - When Using

  • When using this productusing other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.avoid contact with eyes. If contact occurs, flush thoroughly with water.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Cleanse the skin thoroughly before applying the medicationcover the entire affected area with a thin layer one to three times dailybecause 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 doctorif bothersome dryness of peeling occurs, reduce application to once a day or every other day

Other Information

  • Store in a cool dry place away from light

Inactive Ingredients

Water (aqua), coco-caprylate, organic dog rose (rosa canina) fruit oil, glycerin, methylsulfonylmethane (MSM), cetearyl alcohol, cetearyl olivate, citric acid, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, zinc oxide (Cl 77947), sorbitan olivate, caprylic/capric triglyceride, willow (salix nigra) bark extract, oat (avena sativa) kernel flour, organic aloe (aloe barbadensis) leaf juice, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, cetearyl glucoside, glucose, polyhydroxystearic acid, lysolecithin, pullulan, xanthan gum, sclerotium gum, isostearic acid, linalool, limonene, silica, lactoperoxidase, glucose oxidase, organic cypress (cupressus sempervirens) oil, organic lavender (lavandula angustifolia) oil, peppermint (mentha piperita) oil

Otc - Questions

Manufactured for HempFusion(r)
3820 NW 14th Street Suite A & BTopeka, ks 66618877.NOW.HEMP (877.669.4367)hempfusion.com

* Please review the disclaimer below.