NDC 81310-004 Burn Relief Max Strength

Lidocaine, Menthol

NDC Product Code 81310-004

NDC 81310-004-27

Package Description: 1 BOTTLE in 1 BOX > 76.5 g in 1 BOTTLE

NDC Product Information

Burn Relief Max Strength with NDC 81310-004 is a a human over the counter drug product labeled by Stretton Online Ltd.. The generic name of Burn Relief Max Strength is lidocaine, menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Stretton Online Ltd.

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.

Burn Relief Max Strength 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 4 g/100g
  • MENTHOL 1 g/100g

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.

  • CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)
  • PEG-10 GLYCERYL STEARATE (UNII: YTQ40QRP5W)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • WATER (UNII: 059QF0KO0R)
  • CETETH-20 PHOSPHATE (UNII: 921FTA1500)
  • STEARETH-21 (UNII: 53J3F32P58)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • 2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)
  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Stretton Online Ltd.
Labeler Code: 81310
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: 05-05-2021 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.

Burn Relief Max Strength Product Label Images

Burn Relief Max Strength 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 Ingredient
Lidocaine HCI 4%

Menthol 1%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes andinsect bites or minor skin irritations

Warnings

For external use only.

Do Not Use

  • On large areas of the body or on cut, irritated or swollen skinon puncture woundsfor more than one week without consulting a doctor

When Using This Product

  • Use only as directed. Read and follow all directions andwarnings on this carton.WarningsWhen using this productDo not useFor external use only.on large areas of the body or on cut, irritated or swollen skinon puncture woundsfor more than one week without consulting a doctorrare cases of serious burns have been reported with products of this typeif the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,discontinue use of this product and consult a doctor.do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patcha transient burning sensation may occur upon application but generally disappears in several daysavoid contact with eyesavoid contact with mucous membranesdo not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use And Ask A Doctor If

  • Condition worsensredness is presentirritation developssymptoms persist for more than 7 days or clear up and occur again within a few daysyou experience signs of skin injury, such as pain, Swelling, or blistering where the product was applied

Keep Out Of Reach Of Children

If swallowed, get medical help or contact the 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. Children under 2 years of age: consult a doctor.

Other Information

  • Store at room temperatureavoid direct sunlightDo not use if carton is open or if tamper evident foil is breached or missing.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl Propanol, Isohexadecane, Hydroxyethyl Acrylate /Sodium Acryloyldimethyl Taurate Copolymer, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetearyl Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate, Glyceryl Stearate, Dimethicone, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin, SD Alcohol, Steareth-21, Water

Questions

Child-resistant packaging.

Close cap tightly between uses.
Stretton Online Ltd

2160 Union Place

Simi Valley

CA 93065

United States

Medcosa.com

[email protected]

+ 1 (562) 337-0165

* Please review the disclaimer below.