NDC 0295-1110 Sunburnt Plus Pain Relief

Lidocaine Hydrochloride

NDC Product Code 0295-1110

NDC 0295-1110-21

Package Description: 1 TUBE in 1 CARTON > 142 g in 1 TUBE

NDC Product Information

Sunburnt Plus Pain Relief with NDC 0295-1110 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc.. The generic name of Sunburnt Plus Pain Relief is lidocaine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Denison Pharmaceuticals, Llc.

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.

Sunburnt Plus Pain Relief 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 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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
  • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
  • LYTTA VESICATORIA (UNII: 3Q034RO3BT)
  • GELIDIELLA ACEROSA (UNII: T91K54D6M1)
  • HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV)
  • CUCUMBER SEED (UNII: BT3S9L53JK)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • 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: Denison Pharmaceuticals, Llc.
Labeler Code: 0295
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: 03-15-2018 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’.

* Please review the disclaimer below.

Sunburnt Plus Pain Relief Product Label Images

Sunburnt Plus Pain Relief 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

Other

Drug Facts

Dist. by: Welmedix Consumer HealthcarePrinceton, New Jersey 08540

Active Ingredient

Lidocaine hydrochloride 1.0%

Purpose

External analgesic

Uses

  • Temporarily relieves pain and itching due to:sunburnminor burnsinsect bitesminor skin irritationsminor cutsscrapes

Warnings

For external use only

Do Not Use

  • In large quantities, particularly over raw surfaces or blistered areasif you have an allergy or hypersensitivity to any ingredients

Ask A Doctor Before Use If

  • You have severe sunburnyou have a rash or broken or compromised skin

When Using This Product

  • Avoid contact with eyes

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

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

Directions

  • Clean skin and apply to affected areaadults and children 2 years of age and older: apply to affected area not more than 3-4 times dailychildren under 2 years of age: ask a doctor

Other Information

  • Store at 15-30ºC (59-86ºF)do not use if seal under cap is open or missing

Inactive Ingredients

Water, ethyl alcohol, echinacea angustifolia extract, calendula officinalis extract, cantharis vesicatoria extract, gelidiella acerosa extract, hypnea musciformis extract, cucumis sativus (cucumber) seed extract, aloe barbadensis leaf juice, panthenol, sodium hyaluronate, carbomer, sodium hydroxide, phenoxyethanol, ethylhexylglycerin

* Please review the disclaimer below.