Helix Tri-Active Therapy Cream

Helix Tri-Active Therapy Cream by

Drug Labeling and Warnings

Helix Tri-Active Therapy Cream by is a Otc medication manufactured, distributed, or labeled by Parker Laboratories, Inc., Novacyl, Sharp Mint Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HELIX TRI-ACTIVE THERAPY CREAM- pain relieving cream cream 
Parker Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Helix Tri-Active Therapy Cream

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.

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

Store between 20-25°C (68-77°F)

This is a topical analgesic manufactured according to TFM Part 348

Camphor 3.2% .....Topical Analgesic

Menthol 7.4% ….Topical Analgesic

Methyl salicylate 12.5% ………Topical Analgesic

Topical Analgesic

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.

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

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.

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

*simple bachache

*arthritis

*strains

*bruises

*sprains

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.jpg

HELIX TRI-ACTIVE THERAPY CREAM 
pain relieving cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30775-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.2 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM7.4 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE12.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 30775-052-014 in 1 CASE09/01/2021
1100 in 1 BOX
15 g in 1 PACKET; Type 0: Not a Combination Product
2NDC: 30775-052-036 in 1 CASE11/17/2021
212 in 1 BOX
289.325 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 30775-052-046 in 1 CASE11/17/2021
312 in 1 BOX
3119.1 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/01/202106/01/2023
Labeler - Parker Laboratories, Inc. (931423607)
Establishment
NameAddressID/FEIBusiness Operations
Novacyl263624659api manufacture(30775-052)
Establishment
NameAddressID/FEIBusiness Operations
Sharp Mint Limited915787037api manufacture(30775-052)
Establishment
NameAddressID/FEIBusiness Operations
Parker Laboratories, Inc.931423607manufacture(30775-052)

Revised: 9/2023