NDC 0316-0291 Sarna Whipped Foam

Hydrocortisone

NDC Product Code 0316-0291

NDC CODE: 0316-0291

Proprietary Name: Sarna Whipped Foam What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrocortisone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

NDC Code Structure

  • 0316 - Crown Laboratories

NDC 0316-0291-17

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

NDC Product Information

Sarna Whipped Foam with NDC 0316-0291 is a a human over the counter drug product labeled by Crown Laboratories. The generic name of Sarna Whipped Foam is hydrocortisone. The product's dosage form is aerosol, foam and is administered via topical form.

Labeler Name: Crown Laboratories

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

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.

Sarna Whipped Foam 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.

  • HYDROCORTISONE 10 mg/g

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.

  • GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • NITROUS OXIDE (UNII: K50XQU1029)

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.

Product Labeler Information

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

Labeler Name: Crown Laboratories
Labeler Code: 0316
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-15-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sarna Whipped Foam Product Label Images

Sarna Whipped Foam 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

Hydrocortisone 1%

Purpose

Anti-itch

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • insect bites • poison ivy • poison oak • poison sumac • seborrheic dermatitis • psoriasis • other uses of this product should be only under the advice and supervision of a doctor.

Warnings

For external use only. Contents under pressure. Do not puncture or incinerate. Avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes.
Do not use • for external genital, vaginal or anal itching • with other hydrocortisone product unless consulted by a doctor • in or near the eyes • for diaper rash.

Stop Use And Ask A Doctor If

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children

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

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Hold can at an angle and press nozzle lightly. Dispense onto hand and then apply to target area. Wipe nozzle clean after each use. Replace the overcap after each use. Children under 2 years of age: Do not use, consult a doctor.

Other Information

Store between 20° to 25°C (68° to 77°F). Do not store at temperatures above 50°C.

Inactive Ingredients

Benzyl Alcohol, Carbomer, Cetyl Alcohol, Dimethicone, Glycerin, Glyceryl Stearate, Isopropyl Myristate, PEG-100, PEG-100 Stearate, Petrolatum, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearic Acid

Questions

Call 1-833-279-6522Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604Sarna® is a registered trademark of Crown Laboratories, Inc.© 2021 Crown Laboratories, Inc. sarnalotion.comDOT 2Q M5706

Sarna (Hydrocortisone Foam 1%) Whipped Foam - 1.7 Oz Canister Label

Sarna ®Hydrocortisone Foam 1%ECZEMA RELIEFANTI-ITCH whipped foamFast Absorbing, Lightweight FormulaMaximum Strength Formula for Sensitive SkinProvides fast, soothing relief from:ECZEMA, INFLAMMATION, REDNESS, ITCH & MORENo Parabens, Dyes or FragranceNet wt 1.7 oz (48 g)P11841.00

Sarna (Hydrocortisone Foam 1%) Whipped Foam - 1.7 Oz Carton

Sarna ®Hydrocortisone Foam 1%ECZEMA RELIEFANTI-ITCH whipped foamFast Absorbing, Lightweight FormulaMaximum Strength Formula for Sensitive SkinProvides fast, soothing relief from:ECZEMA, INFLAMMATION, REDNESS, ITCH & MORENo Parabens, Dyes or FragranceNet wt 1.7 oz (48 g)P11882.00

* Please review the disclaimer below.