hempvana rollerballs (original)

hempvana rollerballs (original)
SPL v2
SPL
SPL Set ID d91a0fad-a38c-1580-e053-2a95a90ad268
Route
topical
Published
Effective Date 2022-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (10 g)
Inactive Ingredients
edetate disodium anhydrous citric acid monohydrate sodium hydroxide cetostearyl alcohol sunflower oil water ethylhexyl stearate butylene glycol .alpha.-tocopherol acetate phenoxyethanol ethylhexylglycerin peg-100 stearate stearic acid allantoin xanthan gum caprylyl glycol hexylene glycol dimethicone cannabis sativa seed oil glyceryl monostearate medium-chain triglycerides

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-02-28

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 using roller ball applicator
  • Children under 2 years of age:consult a physician
Inactive Ingredients

Water/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Caprylic/Capric Triglyceride, Dimethicone, Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Stearic Acid, Tocopheryl Acetate, Allantoin, Phenoxyethanol, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Citric Acid, Sodium Hydroxide

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

#1 Hemp Pain Relief Brand in America 1

1AC Nielsen 2021 food drug mass POS

Hempvana Brand

Maximum Strength Pain Relief Lotion

Odor Free!

New! 5 Deep Massaging Stainless Steel Rollerballs

Original

+Hemp Seed Oil

For Moisturization

Trolamine Salicylate 10% For Pain

Net Wt. 2.5 OZ (71 g)

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 using roller ball applicator
  • Children under 2 years of age:consult a physician
Inactive Ingredients

Water/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Caprylic/Capric Triglyceride, Dimethicone, Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Stearic Acid, Tocopheryl Acetate, Allantoin, Phenoxyethanol, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Citric Acid, Sodium Hydroxide

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)

#1 Hemp Pain Relief Brand in America 1

1AC Nielsen 2021 food drug mass POS

Hempvana Brand

Maximum Strength Pain Relief Lotion

Odor Free!

New! 5 Deep Massaging Stainless Steel Rollerballs

Original

+Hemp Seed Oil

For Moisturization

Trolamine Salicylate 10% For Pain

Net Wt. 2.5 OZ (71 g)

Section 53414-9 (53414-9)

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

Active Ingredient

Trolamine Salicylate 10%


Advanced Ingredient Data


Raw Label Data

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