hempvana maximum strength pain relief cream - platinum

hempvana maximum strength pain relief cream - platinum
SPL v3
SPL
SPL Set ID d58da6c5-47a6-b8a8-e053-2995a90a7ce7
Route
topical
Published
Effective Date 2022-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (10 g)
Inactive Ingredients
arnica montana flower turmeric dimethyl sulfone .alpha.-tocopherol acetate phenoxyethanol hypromellose, unspecified polysorbate 80 fd&c yellow no. 6 edetate disodium anhydrous ubidecarenone allantoin ethylhexyl stearate stearic acid carbomer interpolymer type a (allyl sucrose crosslinked) caprylyl glycol mannitol microcrystalline cellulose glyceryl monostearate cetostearyl alcohol dimethicone medium-chain triglycerides sunflower oil sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 mw) butylene glycol ferric oxide yellow tocopherol glycerin isohexadecane ethylhexylglycerin sodium hydroxide fd&c blue no. 1 hexylene glycol water cannabis sativa seed oil peg-100 stearate aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-01-14

Purpose

Trolamine Salicylate 10%..........Topical Analgesic

Description

Trolamine Salicylate 10%


Medication Information

Warnings

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Purpose

Trolamine Salicylate 10%..........Topical Analgesic

Directions
  • Adults and children 2 years of age and older:Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age:Consult a physician
  • Massage into painful area until thoroughly absorbed into skin.
  • REpeat as necessary, but no more than 4 times daily.
Inactive Ingredients

Water/Aqua/Eau, Ethylhexyl Stearate, Cannabis Sativa (Hemp) Seed Oil, Butylene Glycol, Stearic Acid, DImethicone, Caprylic/Capric Trigylceride, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Glycerin, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Curcuma Longa (Turmeric) Root Extract, Dimethyl Sulfone, Tocopheryl Acetate, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Isohexadecane, Ethylhexylglycerin, Hexylene Glycol, Allantoin, Mannitol, Microcrystalline Cellulose, Iron Oxides Yellow (CI 77492), Tocopherol, Hydroxypropyl Methylcellulose, Ubiquinone, Polysorbate 80, Sodium Hydroxide, Disodium EDTA, Yellow 6 (CI 15985), Blue 1 (CI 42090)

Description

Trolamine Salicylate 10%

Questions?

Call (855) 877-4503 (M-F, 9am-5pm EST)

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present or irritation develops
Section 50567-7

When using this product

  • Use only as directed. Read and follow all directions and warnings on this label.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not use at the same time as other topical analgesics.
Section 51945-4

Hempvana

Maximum Strength Pain Relief Cream

Platinum

+4x Hemp* Seed Oil

For Moisturization

Trolamine Salicylate 10%

For Pain

Net Wt. 4 oz (119 g)

*Compared to original Hempvana Pain Relief Cream

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Active Ingredient

Trolamine Salicylate 10%


Structured Label Content

Warnings

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Purpose

Trolamine Salicylate 10%..........Topical Analgesic

Directions
  • Adults and children 2 years of age and older:Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age:Consult a physician
  • Massage into painful area until thoroughly absorbed into skin.
  • REpeat as necessary, but no more than 4 times daily.
Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Ethylhexyl Stearate, Cannabis Sativa (Hemp) Seed Oil, Butylene Glycol, Stearic Acid, DImethicone, Caprylic/Capric Trigylceride, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Glycerin, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Curcuma Longa (Turmeric) Root Extract, Dimethyl Sulfone, Tocopheryl Acetate, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Isohexadecane, Ethylhexylglycerin, Hexylene Glycol, Allantoin, Mannitol, Microcrystalline Cellulose, Iron Oxides Yellow (CI 77492), Tocopherol, Hydroxypropyl Methylcellulose, Ubiquinone, Polysorbate 80, Sodium Hydroxide, Disodium EDTA, Yellow 6 (CI 15985), Blue 1 (CI 42090)

Questions?

Call (855) 877-4503 (M-F, 9am-5pm EST)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present or irritation develops
Section 50567-7 (50567-7)

When using this product

  • Use only as directed. Read and follow all directions and warnings on this label.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not use at the same time as other topical analgesics.
Section 51945-4 (51945-4)

Hempvana

Maximum Strength Pain Relief Cream

Platinum

+4x Hemp* Seed Oil

For Moisturization

Trolamine Salicylate 10%

For Pain

Net Wt. 4 oz (119 g)

*Compared to original Hempvana Pain Relief Cream

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Active Ingredient (Active ingredient)

Trolamine Salicylate 10%


Advanced Ingredient Data


Raw Label Data

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