Helix CBD Clinical Cream by Parker Laboratories, Inc. / Sharp Mint Limited Helix CBD Clinical Cream

Helix CBD Clinical Cream by

Drug Labeling and Warnings

Helix CBD Clinical Cream by is a Otc medication manufactured, distributed, or labeled by Parker Laboratories, Inc., Sharp Mint Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HELIX CBD CLINICAL CREAM- helix cbd clinical 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 CBD Clinical Cream

Active Ingredient ... Menthol 7.4%

Purpose... Topical Analgesic

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.

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.

Inactive ingredients: Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Camphor, Cannabis Sativa Seed Oil, 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

Warnings: For external use only.

This is a topical analgesic manufactured according to TFM Part 348

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

simple backache
arthritis
strains
bruises
sprains

Helix CBD Clinical Cream

Helix CBD Clinical Cream

Helix
Professional Pain Relief
​Helix CBD Clinical Cream

ref 54-01

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.

HELIX CBD CLINICAL CREAM 
helix cbd clinical cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30775-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM7.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
TANGERINE PEEL (UNII: JU3D414057)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 30775-054-014 in 1 CASE09/01/2021
1100 in 1 BOX
15 g in 1 PACKET; Type 0: Not a Combination Product
2NDC: 30775-054-0212 in 1 BOX10/04/2021
258.848 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 30775-054-0412 in 1 BOX10/04/2021
3117.696 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
Sharp Mint Limited915787037api manufacture(30775-054)
Establishment
NameAddressID/FEIBusiness Operations
Parker Laboratories, Inc.931423607manufacture(30775-054)

Revised: 9/2023