NDC 44224-5120 After Burn

Lidocaine Hydrochloride

NDC Product Code 44224-5120

NDC 44224-5120-0

Package Description: 1 TUBE in 1 BOX > 59 mL in 1 TUBE

NDC 44224-5120-1

Package Description: 1.8 mL in 1 PACKET

NDC 44224-5120-2

Package Description: 118 mL in 1 TUBE

NDC Product Information

After Burn with NDC 44224-5120 is a a human over the counter drug product labeled by Tender Corporation. The generic name of After Burn is lidocaine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Tender Corporation

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

After Burn 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.

  • LIDOCAINE HYDROCHLORIDE 25 mg/mL

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: Tender Corporation
Labeler Code: 44224
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: 04-12-2011 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.

After Burn 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 Ingredients - After Bite Wipe

Ammonia 3.5%

Purpose - After Bite Wipe

Counterirritant

Use - After Bite Wipe

Temporarily protects and helps relieve minor skin irritation and itching due to - insect bites and stings, poison ivy, oak or sumac

Warnings - After Bite Wipes

For External Use Only

Keep Out Of Reach Of Children - After Bite

Keep out of reach of children: if swallowed, get medical help or contact a Poison Control Center right away

Stop Use - After Bite Wipe

Stop use and ask a doctor if: Condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

When Using - After Bite

Do not get into eyes

Directions - After Bite Wipe

Adults and Children 2 years and older - dab directly on bite or sting, rub gently and reapply as neededChildren under 2 years - ask a doctor

Active Ingredient - Aspirin

Aspirin (NSAID*) 325mg *nonsteroidal anti-inflammatory drug

Purpose - Aspirin

Pain Reliever/Fever Reducer

When Using - Aspirin

Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or Flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters or shock. If an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: this contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others), have 3 or more alcoholic drinks everyday while using this problem, take more for a longer time than directed.Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer; right before or after heart surgery, if you are taking a prescription drug for gout, diabetes or arthritis.Ask a doctor before use if: stomach bleeding warning applies to you, you have a history of stomach problems such as heartburn, you have high blood pressure, heart disease, liver cirrhosis or kidney disease, you are taking a diuretic.Ask a Doctor or Pharmacist before use if you are: under a doctor's care for any serious condition, taking any other drug.When using this product: take with food or milk if stomach upset occursStop use and Ask a Doctor if: you experience any of the following signs of stomach bleeding, you feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, you have difficulty swallowing, if ringing in the ears or loss of hearing occurs, redness or swelling is present in painful areas, or any new symptoms appear.If pregnant or Breastfeeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless directed to do so by a doctor because it may cause problems in the unborn child or complications during deliver.Keep out of reach of Children. In case of overdose, get medical help or contact a poison control center right away.

Directions - Aspirin

Do not use more than directed - the smallest effective dosage should be used. Drink a full glass of water with each dose. Do not take longer than 10 days, unless directed by a doctor.Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours or as directed as a doctor.Children under 12 years: Do not give to children under 12 years of ageAvoid excessive heat and humidity, do not use any open or torn packets.

Use - Aspirin

Temporariy relieves minor aches and pains associated with: headache, muscular aches, minor arthritis pain, backache, common cold, toothache, menstrual cramps, temorarily reduces fever.

Active Ingredient - Ibuprofen

Ibuprofen

Purpose - Ibuprofen

Pain Reliever/Fever Reducer

Use - Ibuprofen

Temporarily relieves minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis, menstrual cramps. Temporarily reduces fever.

Warnings And Precautions - Ibuprofen

Allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing), rash, skin reddening, blisters, and hives, if an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed.Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, fight before or after heart surgery.Ask a doctor before use if stomach bleeding warning applies to you, you have had a history of stomach problems such as heartburn, you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease, you are taking a diuretic.Ask a doctor before use if you are taking any other drug containing NSAID (prescription or nonprescription), taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin, taking any other drug.When using this product take with food or milk if stomach upset occurs.Stop use and ask a doctor if you experience any of the following signs of stomach bleeding, feeling faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, redness or swelling is present in the painful area, any new symptoms appear.If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.Store at controlled room temperature, avoid excessive heat 40 degrees Celsius (104 degrees Fahrenheit); temper evident sealed packets, do not use any opened or torn packets.Do not use more than directed, the smallest effective dose should be used, do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 3 tablets may be use. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: do not give children under 12 years of age.

Active Ingredient - Apap

Acetaminophen 500mg

Purpose - Apap

Analgesic/antipyretic

Uses - Apap

Temporary relief of minor aches and pains associated with: common cold, headache, toothache, muscular aches, backache, arthritis, menstrual cramps, and reduction of fever

Warnings And Precautions - Apap

Liver Warning: This product contains acetaminophen.Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount, child takes more than 5 doses in 24 hours, taken with other drugs containing acetaminophen, adult has 3 or more alcoholic drinks ever day while using this product.Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist, for more than 10 days for pain unless directed by a doctor, for more than 3 days for fever unless directed by a doctor.Ask a doctor before use if the user has liver disease.Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.Stop use and ask a doctor if: symptoms do not improve, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, new symptoms occur, redness or swelling is present, a rare sensitivity reaction occurs.If pregnant or breast-feeding, ask a health professional before use.Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.Store at 59-86 degrees F (15-30 degrees C), tamper evident sealed packets, do not use any open or torn packets.

Directions - Apap

Adult and Children (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.Children 6-11 years take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours.Childen under 6 do not use this product

Active Ingredient - Diphenhydramine

Diphenhydramine Hydrochloride 25mg

Purpose - Diphenhydramine

Antihistamine

Use - Diphenhydramine

Temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose, sneezing, itching nose or throat, itchy-watery eyes.Temporarily relieves these symptoms due to the common cold: runny nose, sneezing

Warnings And Precautions - Diphenhydramine

Do not use to make a child sleepy or with any other product containing diphenhydramine, even one that is used on skin.Ask a doctor before use if you have: a breathing problem such as emphysema or chronic bronchitis, difficulty in urination due to enlargement of the prostate gland, or glaucoma.Ask a doctor pharmacist before you use if you are taking sedatives or tranquilizers.When using this product: marked drowsiness may occur, avoid alcoholic beverages, alcohol, sedatives and tranquilizers may increase the drowsiness effect, use caution when driving a motor vehicle or operating machinery, excitability may occur, especially in children.If pregnant or breast feeding, ask a health professional before use.Keep out of reach of Children. In case of overdose, contact a physician or poison control center immediately.Each caplet may contain calcium 25mg. Store at room temperature 59-86 degrees F (15-30 C), protect from light and use by expiration date on packet. Tamper-evident sealed packets, do not use any opened or torn packets.

Directions - Diphenhydramine

Do not use more than directed.Adults and Children (12 Years and older) - take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.Do not give to children under 12 years of age.

Active Ingredients - After Cuts And Scrapes

Lidocaine Hydrochloride 2.5%Benzalkonium Chloride .13%

Purpose - After Cuts And Scrapes

AnestheticAntiseptic

Uses - After Cuts And Scrapes

First aid for the temporary relief of pain and to protect from infection in minor cuts, scrapes and burns.

Warnings And Precautions - After Cuts And Scrapes

For External Use Only.When using this product: do not get into eyes, do not use in large quantities, particularly over raw surfaces or blistered areas.Stop use and ask a doctor if rash, redness or swelling occurs or pain increases. In case of deep puncture wounds, animal bites or serious burns consult a doctor.If swallowed, get medical help or contact a poison control center right away.If in eyes, flush with water for 15 minutes and call a doctor.Keep out of Reach of Children.

Directions - After Cuts And Scrapes

Shake Well. Clean affected area. Spray on the area 1 to 3 times daily. Adults and children 2 years and older, apply to affected area. Children under 2 years, ask a doctor.

Active Ingredient - After Burn

Lidocaine Hydrochloride 2.5%

Purpose - After Burn

Topical Analgesic

Use - After Burn

For the temporary relief of pain due to minor burns, sunburn, minor cuts, scrapes or minor skin irritations

Warnings And Precautions - After Burn

For external use only. When using this product: avoid contact with eyes, do not use in large quantities, particularly over raw surfaces or blistered areas, do not use longer than 1 week unless directed by a doctor, or in case of deep puncture wounds, animal bites or serious burns, consult a doctor.Stop use and ask a doctor if conditions or 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.If in eyes, flush with water for 15 minutes and call a doctorAdults and Children 2 years and older, apply small amount to affected area, not more than 3 times daily.Children under 2 years, consult a doctor.

Inactive Ingredients - After Burn

Aloe Vera Gel, Benzalkonium Chloride, Carbomer 980, glycerol, USP, herbal fragrance, menthol, polysorbate 20, Propylene glycol, purified water, sodium hydroxide (50%)

* Please review the disclaimer below.