NDC 0096-0732 Aquanil Hc

Hydrocortisone

NDC Product Code 0096-0732

NDC 0096-0732-04

Package Description: 118 g in 1 BOTTLE

NDC 0096-0732-15

Package Description: 16 g in 1 BOTTLE

NDC Product Information

Aquanil Hc with NDC 0096-0732 is a a human over the counter drug product labeled by Person And Covey. The generic name of Aquanil Hc is hydrocortisone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Person And Covey

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Aquanil Hc 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 .01 g/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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

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: Person And Covey
Labeler Code: 0096
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: 01-08-1995 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’.

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Information for Patients

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticos...
[Read More]

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Aquanil Hc Product Label Images

Aquanil Hc 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

Stop Use And Ask A Doctor

Stop use and ask a doctor if:-Condition worsens-If symptoms persit for more than 7 days or clear up and occur again within a few days. Discocntinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.-Do no use for diaper rash. Consult a doctor.

Keep Out Of The Reach Of Children

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

Purpose

Antipruritic (Anti-itch)

Directions

-Shake will before using.-For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.-For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a ddoctor.-Store away from excessive heat or cold.

Inactive Ingredients

Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Laureth Sulfate, Stearyl Alcohol, Simethicone, Xanthan Gum

Questions?

Questions? Please call (800) 423-2341

Uses

For the temporary relief of minor skin irritations, inflamaations, itching and rashes caused by:-insect bites-eczema-psoriasis-soaps-detergents-cosmetics,-jewelry,-poison oak,-poison sumac-Other uses of this product should be undertaken only under the advice and supervision of a doctor.

Warnings

For external use only.Do not get into eyes. If contact occurs, rinse thoroughly with water.

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