NDC 71131-100 Kivoria Acne Wash

Benzoyl Peroxide

NDC Product Code 71131-100

NDC Product Information

Kivoria Acne Wash with NDC 71131-100 is a a human over the counter drug product labeled by Uberscientific, Llc. The generic name of Kivoria Acne Wash is benzoyl peroxide. The product's dosage form is soap and is administered via topical form.

Labeler Name: Uberscientific, Llc

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Kivoria Acne Wash Active Ingredient(s)

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

  • BENZOYL PEROXIDE 10 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • THYMUS VULGARIS LEAF (UNII: GRX3499643)
  • WATER (UNII: 059QF0KO0R)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CARBOMER 934 (UNII: Z135WT9208)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • HYDROXIDE ION (UNII: 9159UV381P)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

Administration Route(s)

Additional informationCallout TooltipWhat 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.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Uberscientific, Llc
Labeler Code: 71131
FDA Application Number: part333D Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 04-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Kivoria Acne Wash Product Label Images

Kivoria Acne Wash 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

Drug Facts

Active IngredientBenzoyl Peroxide 10%

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, use only one topcial acne medication at a time).Avoid unnecessary sun exposure and use a sunscreenAvoid contact with the eyes, lips, and mouthAvoid contact with hair and dyed fabrics, which may be bleached by this productSkin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swellingIrritation may be reduced byusing the product less frequently or in a lower concentration.

Do Not Use

  • If you have very sensitive skinIf you are sensitive to benzoyl peroxideIf safety evident features have been breached or missing

Stop Use And Ask A Doctor

  • If irritation becomes more severe

Keep Out Of Reach Of Children.

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

Directions

Sensitivity test for a new user: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, apply the acne wash and gently massage into damp skin. Wait 3 to 5 minutes to absorb, and then thoroughly rinse area with water. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops stop use and ask a doctor.

Other Ingredients

Aloe Barbadensis (aloe vera gel) Juice, Deionized Water, Ascorbic Acid (Vitamin C), Camella Sinensis (Green Tea) Leaf Extract, Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide, Thymus Vulgaris (Thyme) Extract, Hydroxide, Thymus Vulgaris (Thyme) Extract.

Distributed By

Uber Scientific, LLC3211 Vineland Rd. Suite 250(302) 566-8237

Pdp

KIVORIA Acne Wash10% Benzoyl Peroxide8fl oz | 226gCruelty FreeMade in USA

* Please review the disclaimer below.

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