NDC 30775-052 Helix Tri-active Therapy Cream

Pain Relieving Cream

NDC Product Code 30775-052

NDC CODE: 30775-052

Proprietary Name: Helix Tri-active Therapy Cream 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: Pain Relieving Cream 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.

Product Characteristics

Color(s):
YELLOW (C48330)

NDC Code Structure

  • 30775 - Parker Laboratories, Inc.

NDC 30775-052-01

Package Description: 4 BOX in 1 CASE > 100 PACKET in 1 BOX > 5 g in 1 PACKET

NDC Product Information

Helix Tri-active Therapy Cream with NDC 30775-052 is a a human over the counter drug product labeled by Parker Laboratories, Inc.. The generic name of Helix Tri-active Therapy Cream is pain relieving cream. The product's dosage form is cream and is administered via topical form.

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.

Helix Tri-active Therapy Cream 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.


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.

  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • 1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE, TRANS-(+/-)- (UNII: 8L3TU41CCC)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)
  • MANDARIN OIL (UNII: NJO720F72R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Parker Laboratories, Inc.
Labeler Code: 30775
FDA Application Number: part356 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: 09-01-2021 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.

Helix Tri-active Therapy Cream Product Label Images

Helix Tri-active Therapy Cream 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

Warnings

WarningsFor 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. 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.

Instructions For Use

For external use onlyUses:For the temporary relief of minor aches and pains of muscles and joints associated with:▪simple backache arthritis▪strains▪bruises▪sprainDirectionsAdults and children 2 years of age and older: ▪Rub a thin film over affected areas not more than4 times daily▪Wash hands after each use with cool waterChildren under 2 years of age: Consult a physician

Storage And Handling

Store between 20-25°C (68-77°F)

Other

This is a topical analgesic manufactured according to TFM Part 348

Otc - Active Ingredient

Camphor 3.2% .....Topical Analgesic Menthol 7.4% ….Topical Analgesic Methyl salicylate 12.5% ………Topical Analgesic

Otc - Purpose

Topical Analgesic

Otc - Stop Use

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

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.

Inactive Ingredient

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Carbomer, Citrus Reticulata (Tangerine) Oil, D&C Orange No.4, Dimethicone, Ethylhexylglycerin, FD&C Yellow No.5, Fragrance, Ilex Paraguerensis Leaf Extract, Isopropyl Alcohol, Lauryl PEG/PPG-18/18 Methicone, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, Water

Otc - 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 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.

Indications & Usage

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

* Please review the disclaimer below.