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

Helix by

Drug Labeling and Warnings

Helix 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 therapy 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 Therapy 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 a 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.

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

Warning: 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 Therapy Cream Label

Helix
Professional Pain Relief
​Helix CBD Therapy Cream

ref 53-01

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 therapy cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30775-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	7.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TANGERINE PEEL (UNII: JU3D414057)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30775-053-01	4 in 1 CASE	09/01/2021
1		100 in 1 BOX
1		3 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 30775-053-02	12 in 1 BOX	10/04/2021
2		58.896 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 30775-053-04	12 in 1 BOX	10/04/2021
3		117.792 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	09/01/2021	06/01/2023

Labeler - Parker Laboratories, Inc. (931423607)

Establishment
Name	Address	ID/FEI	Business Operations
Sharp Mint Limited		915787037	api manufacture(30775-053)

Establishment
Name	Address	ID/FEI	Business Operations
Parker Laboratories, Inc.		931423607	manufacture(30775-053)

Revised: 9/2023

Document Id: 05a4985f-8320-e833-e063-6294a90a094b

34390-5

Set id: cc0e205a-697c-d47e-e053-2995a90a154e

Version: 3

Effective Time: 20230918