Helix Tri-active Therapy Cream

Pain Relieving Cream

Parker Laboratories, Inc.
Human Otc Drug
NDC 30775-052

Helix Tri-active Therapy Cream also known as Pain Relieving Cream is a human otc drug labeled by 'Parker Laboratories, Inc.'. National Drug Code (NDC) number for Helix Tri-active Therapy Cream is 30775-052. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Helix Tri-active Therapy Cream drug includes Camphor (natural) - 3.2 g/100g Menthol, Unspecified Form - 7.4 g/100g Methyl Salicylate - 12.5 g/100g . The currest status of Helix Tri-active Therapy Cream drug is Active.

Drug Information:

Drug NDC:	30775-052
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 Tri-active Therapy Cream
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:	CAMPHOR (NATURAL) - 3.2 g/100g MENTHOL, UNSPECIFIED FORM - 7.4 g/100g METHYL SALICYLATE - 12.5 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:	01 Sep, 2021
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, 2024
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:	2570566
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:	N20HL7Q941 L7T10EIP3A LAV5U5022Y
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
30775-052-01	4 BOX in 1 CASE (30775-052-01) / 100 PACKET in 1 BOX / 5 g in 1 PACKET	01 Sep, 2021	N/A	No
30775-052-03	6 BOX in 1 CASE (30775-052-03) / 12 TUBE in 1 BOX / 89.325 g in 1 TUBE	17 Nov, 2021	N/A	No
30775-052-04	6 BOX in 1 CASE (30775-052-04) / 12 TUBE in 1 BOX / 119.1 g in 1 TUBE	17 Nov, 2021	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.

Other medicines with the same generic name

Dynarub

Pain Relieving Cream

Cream
Dynarex Corporation
NDC: 67777-113

Helix Tri-active Therapy Cream

Pain Relieving Cream

Cream
Parker Laboratories, Inc.
NDC: 30775-052

Burnzone

Pain Relieving Cream

Cream
MedZone Products LLC
NDC: 70338-621

Helix

Pain Relieving Cream

Cream
Parker Laboratories, Inc.
NDC: 30775-051

Purpose:

Topical analgesic

Product Elements:

Helix tri-active therapy cream pain relieving cream fd&c yellow no. 5 1-(2,3,8,8-tetramethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-yl)ethanone, trans-(+/-)- aloe vera leaf d&c orange no. 4 camphor (natural) camphor (natural) menthol, unspecified form menthol, unspecified form mandarin oil phenoxyethanol methyl salicylate salicylic acid isopropyl alcohol arnica montana flower carbomer homopolymer, unspecified type ethylhexylglycerin ilex paraguariensis leaf dimethicone lauryl peg/ppg-18/18 methicone polyoxyl 40 hydrogenated castor oil propylene glycol sodium hydroxide water

Indications and Usage:

Uses: for the temporary relief of minor aches and pains of muscles and joints associated with: *simple bachache *arthritis *strains *bruises *sprains

Warnings:

Warnings for external use only. when using this product âªavoid contact with eyes or mucous membranesâªdo not apply to wounds or damaged skinâªdo not bandage tightlyâªwash hands with cool water after useâªdo not use with heating pad or deviceâªstop 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 condition worsens, or if symptoms persist for more than 7 days or clear up and recur. 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.

When Using:

When using this product: avoid contact with eyes or mucous membranes do not apply to wounds or damaged skin do not bandage tightly wash hands with cool water after use do not use with heating pad or device 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 admin adults and children 2 years of age and older: *rub a thin film over affected areas not more than 4 times daily. *wash hands after each use with cool water. children under 2 years of age: consult a phtsician.

Stop Use:

Discontinue use and consult doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and recur

Package Label Principal Display Panel:

Helix professional pain relief âtri-active therapy cream ref 52-01 arnica-ilex-tangerine oil use for sore muscles - joint pain - arthritis - backache uses: for the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains warnings: for external use only. when using this product: avoid contact with eyes or mucous membranes do not apply to wounds or damaged skin do not bandage tightly wash hands with cool water after use do not use with heating pad or device 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 condition worsens, or if symptoms persist for more than 7 days or clear up and recur keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. 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: rub a thin film over affected areas not more than 4 times daily wash hands after each use with cool water children under 2 years of age: consult a physician. storage: store between 20-25Â°c (68-77Â°f) helix tri-active therapy cream.jpg

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.