NDC 0498-0801 Hydrocortisone

Anti-itch

NDC Product Code 0498-0801

NDC CODE: 0498-0801

Proprietary Name: Hydrocortisone 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: Anti-itch 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 hemorrhoids and itching/swelling in the rectum and anus. It is also used with other medications to treat certain intestinal problems (such as ulcerative colitis of the rectum and other rectal/anal inflammatory conditions). Hydrocortisone suppositories help to relieve rectal pain, itching, bloody diarrhea, and bleeding by reducing swelling (inflammation) directly in the rectum and anus. Hydrocortisone belongs to a class of drugs called corticosteroids.

NDC Code Structure

NDC 0498-0801-01

Package Description: 1728 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC 0498-0801-02

Package Description: 144 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-03

Package Description: 25 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-32

Package Description: 20 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-33

Package Description: 100 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-34

Package Description: 10 PACKET in 1 BOX, UNIT-DOSE > .9 g in 1 PACKET

NDC 0498-0801-35

Package Description: .9 g in 1 PACKET

NDC Product Information

Hydrocortisone with NDC 0498-0801 is a a human over the counter drug product labeled by Honeywell Safety Products Usa, Inc. The generic name of Hydrocortisone is anti-itch. The product's dosage form is cream and is administered via topical form.

Labeler Name: Honeywell Safety Products Usa, Inc

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.

Hydrocortisone 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 ACETATE 1 g/100g

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: Honeywell Safety Products Usa, Inc
Labeler Code: 0498
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: 10-15-2019 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’.

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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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Hydrocortisone 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

Eyesaline Active Ingredient

Sterile Water 99%

Eyesaline Purpose

Eyewash

Eyesaline Uses

  • For flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Eyesaline Warnings

For external use only-Obtain immediate medical treatment for all open wounds in or near eyes.To avoid contamination, do not touch tip of container to any surface.Do not reuse. Once opened, discard.

Do Not Use

  • If solution changes color or becomes cloudyif you have open wounds in or near the eyes, get medical help right away.

  • In the eyes over large areas of the body

  • In the eyesover large areas of the body

  • In the eyesover large areas of the body

  • In or near the eyesover large areas of the body

  • In or near the eyes or other mucous membranesin case of serious burnsin case of deep or puncture woundsfor prolonged period of timeon large portion of the body

Stop Use And Ask A Doctor If

  • You experience eye painchanges in visioncontinued redness or irritation of the eyecondition worsens or persists

  • A rash or other allergic reaction developsyou need to use longer than 1 week

  • The condition persists or gets worsea rash or other allergic reaction developsyou need to use longer than 1 week

  • The condition persists or gets worse

  • Condition worsens or symptoms persist for more than 7 dayscondition clears up and recurs within a few daysredness, swelling, or irritation occurs

  • Condition worsenscondition persists for more than 7 dayscondition clears up and recurs within a few days

Keep Out Of Reach Of Children

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

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

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

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

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

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

Eyesaline Directions

  • Remove contacts before usingtwist top to removeflush the affected area as neededcontrol rate of flow by pressure on the bottleif necessary, continue flushing with emergency eyewash or shower

Eyesaline Inactive Ingredients

Sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyesaline Questions

1-800-430-5490 Honeywell Sadety Products USA, Inc. Smithfield, RI 02917

Alcohol Wipe Active Ingredient

Isopropyl alcohol 70%

Alcohol Wipe Purpose

First aid antiseptic

Alcohol Wipe Uses

  • First aid to help prevent infection in minor cuts, scrapes, and burns

Alcohol Wipe Warnings

For external use only

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsanimal bitesserious burn

  • Deep or puncture woundsanimal bitesserious burns

  • Deep or puncture woundsanimal bitesserious burns

When Using This Product

  • Do not use longer than one week unless directed by a doctor

  • Do not use longer than one week unless directed by a doctor

  • Do not use in the eyes discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

Stop Use And Consult A Doctor

  • If condition persists or gets worse

Alcohol Wipe Directions

  • Clean the affected areaapply wipe to affected area 1 to 3 times dailymay be covered with a sterile bandagediscard wipe after single use

Alcohol Wipe Other Information

Store at room temperature 15
0 to 25
0 C (59
0 to 77
0F)

Alcohol Wipe Inactive Ingredient

Water

Alcohol Wipe Questions

1-800-430-5490

Neomycin Active Ingredient

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Neomycin Purpose

First aid antibiotic

Neomycin Uses

  • First aid to help prevent infection in - minor cuts - scrapes - burns

Neomycin Warnings

For external use only

Neomycin Direction

  • Clean the affected areaapply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times dailymay be covered with a sterile bandage

Neomycin Other Information

Store at 15
0 to 25
0 C (59
0 to 77
0 F)

Neomycin Inactive Ingredient

Petrolatum

Neomycin Questions?

1-800-430-5490

Antiseptic Spray Active Ingredient

Benzalkonium chloride 0.13%

Antiseptic Spray Purpose

First aid antiseptic

Antiseptic Spray Uses

  • First aid to help prevent infection in minor cuts, scrapes and burns

Antiseptic Spray Warnings

For external use only

Antiseptic Spray Directions

  • Clean the affected areaspray a small amount of this product on the area 1 to 3 times dailymay be covered with a sterile bandageif bandaged, let dry first

Antiseptic Spray Other Information

  • Shake wellstore at room temperature 15
  • 0-30
  • 0 C (59
  • 0 -86
  • 0 F)

Antiseptic Spray Inactive Ingredients

Diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, water

Antiseptic Spray Questions

1-800-430-5490

Burn Spray Active Ingredient

Benzethonium chloride 0.2% w/wBenzocaine 10% w/w Menthol 0.33% w/w

Burn Spray Purpose

Benzethonium chloride 0.2% w/wBenzocaine 10% w/w Menthol 0.33% w/w

Burn Spray Uses

  • For the temporary relief of pain and itching and helps protect against infection in:minor cuts and scrapesburnssunburninsect bitesminor skin irritations

Burn Spray Warnings

  • For external use onlyFlammablekeep away from fire or flamecontents under pressuredo not puncture or incinerate containerdo not expose to temperatures above 120 0 F

Keep Out Of The Reach Of Children

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

Burn Spray Directions

  • Clean the affected areashake can well before usinghold 4 - 6 inches from surface and spray area until wetmay be covered with a sterile bandage, if bandaged let dry firstfor adult institutional use onlynot intended for use on children

Burn Spray Other Information

  • Avoid inhaling use only as directedintentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal

Burn Spray Inactive Ingredients

Dipropylene glycol, isobutane, n-butane, propane

Hans Sanitizer Active Ingredient

Ethyl alcohol 62%

Hand Santizer Purpose

Antiseptic handwash

Hand Sanitizer Uses

  • For hand washing to decrease bacteria on skinrecommended for repeated use

Hand Sanitizer Warnings

For external use only Flammable, keep away from fire or flame

Hand Sanitizer Directions

  • Wet hands thoroughly with product and allow to dry without wiping

Hand Sanitizer Other Information

Store at 15
0 to 25
0 C (59
0 to 77
0 F)

Hand Sanitizer Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

Hydrocortisone Active Ingredient (In Each Gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Hydrocortisone Purpose

Anti-itch cream

Hydrocortisone Uses

  • For the temporary relief of itching associated with minor skin irritations and rashes

Hydrocortisone Warnings

For external use ;only

Ask A Doctor Before Use If

  • If you are using any other hydrocortisone product

When Using The Product

  • Avoid contact with eyesdo not begin use of any other hydrocortisone product unless you have consulted a doctordo not use for the treatment of diaper rash

Hydrocortisone Directions

  • Adults and children 2 years and older:clean the affected areaapply to the area not more than 3 to 4 times dailychildren under 2 years of age: consult a doctor

Hydrocortisone Other Information

  • Store at room temperature (do not freeze)

Hydrocortisone Inactive Ingredients

Cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

4360 Kit Contnets Frksoftpak-Clsb

1 1 X 3 WOVEN 100/BOX3 NEOMYCIN ANTIBIOTIC 10 PER2 EYE DRESS PKT W/4 ADH STRIPS1 TOURNIQUET, 1 PER1 WIRE SPLINT 1 PER1 RESCUE BLANKET 1 PER1 GAUZE COMP, 18" X 36", 2 PER1 BANDAGE COMP, 2" OFFSET, 4 PER1 ALCOHOL PREP PADS 10P1 HYDROCORTISON,1.O%,1/32 OZ,10P1 O/H PAK,ADH BDG 2"X4", X-LG,10 PER1 O/H PUMP ANTISEPTIC 2 OZ ID F1 O/H PUMP BURN RELIEF 2 OZ ID G1 FIRST AID GUIDE ASHI1 TAPE ADHESIVE 1"X 5 YD PLSTC10 HAND SANITIZER 0.9G WJ BULK2 GAUZE CLEAN-WRAP BDGE N/S 2"1 GAUZE CLEAN-WRAP BDGE N/S 4"4 BLOODSTOPPER1 GZE PADS STERILE 3"X 3" 10'S1 ELASTIC BANDAGE 3" X 4.5YD1 CPR FILTERSHIELD 77-1001 4OZ BFS EYEWASH TRILINGUAL BOTTLE1 SCISSOR BDGE 4" RED PLS HDL1 KIT TWEEZER 3 1/2" SLANTEDLBL STOCK 6-3/8"X4"LBL STOCK 4"X2-7/8"1 LBL STOCK 3"x1-7/8"4 PR LRG NITRILE GLVES2 WATER-JEL BURN DRESSING 4 X 41 KIT BAG SOFT PACK LARGE1 LBL CONTENTS ANSI 2015 CL B2 TRI BNDG NON WOVEN 40"X40"X56"2 COLD PACK UNIT 4"X6" BULK4 WOVEN FINGERTIP BANDAGE 2"6 WOVEN KNUCKLE BANDAGE

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