NDC 11822-3788 Icy Hot With Lidocaine No-mess

Menthol And Lidocaine

NDC Product Code 11822-3788

NDC CODE: 11822-3788

Proprietary Name: Icy Hot With Lidocaine No-mess 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: Menthol And Lidocaine 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 relieve nerve pain after shingles (infection with the herpes zoster virus). This type of pain is called post-herpetic neuralgia. Lidocaine helps to reduce sharp/burning/aching pain as well as discomfort caused by skin areas that are overly sensitive to touch. Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

NDC Code Structure

  • 11822 - Rite Aid Hdgrts Corp

NDC 11822-3788-9

Package Description: 70.8 g in 1 BOTTLE

NDC Product Information

Icy Hot With Lidocaine No-mess with NDC 11822-3788 is a a human over the counter drug product labeled by Rite Aid Hdgrts Corp. The generic name of Icy Hot With Lidocaine No-mess is menthol and lidocaine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Rite Aid Hdgrts Corp

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Icy Hot With Lidocaine No-mess 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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)

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: Rite Aid Hdgrts Corp
Labeler Code: 11822
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: 09-30-2020 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.

Icy Hot With Lidocaine No-mess Product Label Images

Icy Hot With Lidocaine No-mess 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

Lidocaine HCLMenthol

Purposes

Lidocaine HCl 4%............................................................................................................................Topical anestheticMenthol 1%.......................................................................................................................................Topical analgesic

Use

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

■ on large areas of the body or on cut, irritated or swollen skin


■ on puncture wounds


■ for more than one week without consulting a doctor

When Using This Product

■ use only as directed. Read and follow all directions and warnings on this carton.


■ avoid contact with eyes and mucous membranes■ rare cases of serious burns have been reported with products of this type


■ do not apply to wounds or damaged, broken or irritated skin■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use■ a transient burning sensation may occur upon application but generally disappears in several days■ avoid applying into skin folds

Stop Use And Ask A Doctor If

■ condition worsens


■ redness is present■ irritation develops■ symptoms persist for more than 7 days or clear up and occur again within a few days■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Adults and children over 12 years:■ apply a thin layer to affected area not more than 3 to 4 times daily■ massage into painful area until thoroughly absorbed into skin■


IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATERchildren 12 years or younger: ask a doctor

Inactive Ingredients

2-amino-2methylpropanol, acrylates/C10-30 alkyl acrylate crosspolymer, aloe vera juice, caprylyl methicone, cetearyl alcohol, cetyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polysorbate 60, purified water, stearyl alcohol

* Please review the disclaimer below.