NDC 73318-4320 Resurfacing Acne Swipes

Salicylic Acid

NDC Product Information

Resurfacing Acne Swipes with NDC 73318-4320 is a a human over the counter drug product labeled by Skin Ps Brands. The generic name of Resurfacing Acne Swipes is salicylic acid. The product's dosage form is swab and is administered via topical form.

Labeler Name: Skin Ps Brands

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

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.

Resurfacing Acne Swipes 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 .02 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.

  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • AZELAIC ACID (UNII: F2VW3D43YT)
  • WATER (UNII: 059QF0KO0R)
  • FYTIC ACID (UNII: 7IGF0S7R8I)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • GLUCONIC ACID (UNII: R4R8J0Q44B)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68)
  • RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • LACTIC ACID, L- (UNII: F9S9FFU82N)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
  • KOJIC ACID (UNII: 6K23F1TT52)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • ARBUTIN (UNII: C5INA23HXF)
  • GLUTATHIONE (UNII: GAN16C9B8O)

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: Skin Ps Brands
Labeler Code: 73318
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: 12-01-2019 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: 12-31-2020 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.

Resurfacing Acne Swipes Product Label Images

Resurfacing Acne Swipes 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 2.0%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

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.

Keep Out Of Reach Of Children

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

Directions

• after cleansing, use one (1) pad to sweep

over dry face with focus on acne-prone

areas of the skin

• Can be used up to two times daily or as

tolerated by skin

• Because 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 doctor

• If bothersome dryness or peeling occurs,

reduce application to once a day or every

other day.

• Sensitivity Test for a New User:

apply product sparingly to one or two small

affected areas during first 3 days. If no

discomfort occurs, follow directions above.

Other Information

Store in a coo, dry place

Inactive Ingredients

Water, Sodium Hydroxide, Glycolic Acid, Lactic

Acid, Phytic Acid, Polysorbate 20, Propanediol,

Glycerin, Carica Papaya (Papaya) Fruit Extract,

Chamomilla Recutita (Matricaria) Flower

Extract, Heterotheca Inuloides Flower Extract,

Hamamelis Virginiana (Witch Hazel)

Bark/Leaf/Twig Extract, Ricinus Communis

(Castor) Seed Oil, Maltodextrin, Kojic Acid,

Niacinamide, Arbutin, Glutathione, Azelaic Acid,

Dipotassium Glycyrrhizate, Decyl Glucoside,

Polyglyceryl-10 Caprylate/Caprate,

Coco-Glucoside, Glyceryl Oleate, Retinyl

Palmitate, Sodium Chloride, Gluconic Acid,

Citric Acid, Sodium Benzoate, Potassium

Sorbate, Phenoxyethanol, Ethylhexylglycerin.

Label

SLMD Sandra Lee MDResurfacing Acne Swipes5% Glycolic Acid2% Salicylic Acid45 pre-soaked padsCreated by Dr. Pimple PopperSwipe to reveal clear, glowing skinDermatologist formulated ,skina pprovedCreated by pop culture's favoritedermatologist, SLMD Skincare was

formulated by Sandra Lee, MD to bridge

the gap between the cluttered skincare

aisle and a doctor’s visit. You can trust

each bottle will contain only the most

effective ingredients, in formulas that your

skin will love. Think of it as a trip to Dr.

Pimple Popper’s office, no appointment

necessary.
Resurfacing Acne SwipesThese acne-fighting, texture perfecting

pads begin with a cocktail of three major

skincare acids: Salicylic, Glycolic, and Lactic.

Together, this trio works to exfoliate and

clarify by sloughing away dull skin at the

surface and diving deep to remove

pore-clogging impurities. Loaded into soft

woven rounds, swipe these on to prevent

acne and reveal a healthy, noticeable glow.

Resurfacing Acne
How to use:After cleansing, swipe a single pad all over

the face, avoiding the eye area. Use up to

2x daily, or as tolerated by skin.
Questions or comments?

Visit us at slmdskincare.com

@slmdskincare

Distributed by Skin PS Brands

Culver City, CA 90232

Assembled in the USA

* Please review the disclaimer below.