Helix Tri-Active Therapy Cream

Manufacturer
Parker Laboratories, Inc. | Novacyl | Sharp Mint Limited
Effective date
2023-01-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:39:45

Label at a glance#

ProductHelix Tri-Active Therapy Cream
Active ingredientCAMPHOR (NATURAL), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure13 sections

Storage and handling

Store between 20-25°C (68-77°F)

Label contents#

Full prescribing information#

WARNINGS SECTION

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. 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 SECTION

For external use only

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with:▪simple backache arthritis▪strains▪bruises▪sprain

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 AND HANDLING SECTION

Store between 20-25°C (68-77°F)

SPL UNCLASSIFIED SECTION

This is a topical analgesic manufactured according to TFM Part 348

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.2% .....Topical Analgesic

Menthol 7.4% ….Topical Analgesic

Methyl salicylate 12.5% ………Topical Analgesic

OTC - PURPOSE SECTION

Topical Analgesic

OTC - STOP USE SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with:

*simple bachache

*arthritis

*strains

*bruises

*sprains

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helix
Professional Pain Relief
​Tri-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 20-25°C (68-77°F)

Helix Tri-Active Therapy Cream.jpgHelix Tri-Active Therapy Cream.jpg

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30775-05230775-052-01, 30775-052-03, 30775-052-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
05a4985f-8319-e833-e063-6294a90a094bc9d78e29-f3af-89e9-e053-2a95a90a75c12023-09-18WarningsExact identifier
spl set id: c9d78e29-f3af-89e9-e053-2a95a90a75c1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.