Helix
Pain Relieving Cream
Parker Laboratories, Inc.
Human Otc Drug
NDC 30775-051Helix also known as Pain Relieving Cream is a human otc drug labeled by 'Parker Laboratories, Inc.'. National Drug Code (NDC) number for Helix is 30775-051. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Helix drug includes Menthol, Unspecified Form - 7.4 g/100g . The currest status of Helix drug is Active.
Drug Information:
| Drug NDC: | 30775-051 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Helix |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Pain Relieving Cream |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Parker Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MENTHOL, UNSPECIFIED FORM - 7.4 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 23 Aug, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part356 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Parker Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2120690
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | L7T10EIP3A
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 30775-051-01 | 4 BOX in 1 CASE (30775-051-01) / 100 PACKET in 1 BOX / 5 g in 1 PACKET | 23 Aug, 2018 | N/A | No |
| 30775-051-03 | 6 BOX in 1 CASE (30775-051-03) / 12 BOTTLE, WITH APPLICATOR in 1 BOX / 85.06 g in 1 BOTTLE, WITH APPLICATOR | 23 Aug, 2018 | N/A | No |
| 30775-051-04 | 6 BOX in 1 CASE (30775-051-04) / 12 TUBE in 1 BOX / 114.46 g in 1 TUBE | 23 Aug, 2018 | N/A | No |
| 30775-051-12 | 4 BOX in 1 CASE (30775-051-12) / 12 BOTTLE, PUMP in 1 BOX / 343.38 g in 1 BOTTLE, PUMP | 23 Aug, 2018 | N/A | No |
| 30775-051-32 | 2 BOX in 1 CASE (30775-051-32) / 6 BOTTLE, PUMP in 1 BOX / 917.62 g in 1 BOTTLE, PUMP | 23 Aug, 2018 | N/A | No |
| 30775-051-50 | 4 BOTTLE, PUMP in 1 CASE (30775-051-50) / 3686 g in 1 BOTTLE, PUMP | 23 Aug, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic
Product Elements:
Helix pain relieving cream menthol, unspecified form menthol, unspecified form ethylhexylglycerin phenoxyethanol camphor (natural) isopropyl alcohol lauryl peg/ppg-18/18 methicone aloe vera leaf tangerine peel sodium hydroxide propylene glycol water ilex paraguariensis leaf carboxypolymethylene hydrogenated castor oil arnica montana flower methyl dihydrojasmonate (synthetic) ethyl linalool hexamethylindanopyran ethylene brassylate benzyl salicylate pentadecalactone tetramethyl acetyloctahydronaphthalenes 2-isobutyl-4-methyltetrahydropyran-4-ol
Indications and Usage:
Indications and usage
Warnings:
Warnings warnings for external use only. when using this product avoid contact with eyes or mucous membranes â do not apply to wounds or damaged skin â do not bandage tightly â wash hands with cool water after use â do not use with heating pad or device â stop use and ask a doctor if you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
Dosage and Administration:
Dosage and administration from drug facts label
Package Label Principal Display Panel:
Primary package (packet) label including drug facts box drug facts active ingredient purpose menthol 7.4% ................................................................... topical analgesic uses for the temporary relief of minor aches and pains of muscles and joints associated with: â simple backache â arthritis â strains â bruises â sprains warnings for external use only. when using this product avoid contact with eyes or mucous membranes â do not apply to wounds or damaged skin â do not bandage tightly â wash hands with cool water after use â do not use with heating pad or device â stop use and ask a doctor if you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied. discontinue use and consult doctor if â condition worsens, or if symptoms persist for more than 7 days or clear up and recur flammable: keep away from fire or flame if pregnant or breastfeeding, 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 2 years of age and older: â rub a thin film over affected areas not more than 4 times daily â wash hands after each use with cool water children under 2 years of age: consult a physician inactive ingredients aloe barbadensis leaf extract, arnica montana flower extract, camphor, carbomer, citrus reticulata (tangerine) oil, ethylhexylglycerin, fragrance, ilex paraguerensis leaf extract, isopropyl alcohol, lauryl peg/ppg-18/18 methicone, peg-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, sodium hydroxide, water ©2018 parker laboratories, inc. 286 eldridge road, fairfield, nj 07004 u.s.a. questions (toll free) 800-631-8888 helix4pain.com cm-034-0001a packet label