SPL v3
SPL
SPL Set ID 1030d478-6805-6579-e063-6294a90a0c76
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Ocimum Basilicum (basil) Flower/leaf Extract Eclipta Prostrata Whole Melia Azedarach Whole Aloe Barbadensis Flower Extract Curcuma Longa (turmeric) Root Extract Ocimum Tenuiflorum Whole Peg-100 Stearate Glyceryl Monostearate Cannabis Sativa Seed Oil Sodium Hydroxide Stearic Acid Lavandula Angustifolia Flower Ethylhexyl Palmitate Water Cetostearyl Alcohol Glycerin Isohexadecane Hexylene Glycol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Phenoxyethanol Dimethicone Lavender Oil Allantoin Piper Methysticum Root Potassium Cetyl Phosphate Alpha-tocopherol Acetate Cocoa Butter Propylene Glycol Chamaemelum Nobile Flower Melatonin Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Caprylyl Glycol Ethylhexylglycerin Polysorbate 80 Edetate Disodium Anhydrous Corallina Officinalis Extract Melia Azadirachta Leaf Coccinia Indica Fruit Extract Moringa Oleifera Seed Oil Solanum Melongena Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-30

Description

Lidocaine 4%

Purpose

Lidocaine 4%...... Topical Analgesic


Medication Information

Purpose

Lidocaine 4%...... Topical Analgesic

Description

Lidocaine 4%

Uses

For the temporary relief of pain

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.

■ do not use in large quantities, particularly over raw surfaces or blistered areas.

Section 51945-4

​Hempvana

Ultra Strength

Pain Relief

Cream

Lidocaine 4%

Overnight

Calming Scent of Lavender

+ Hemp Seed Oil

For Moisturization

Net Wt. 3oz (85 g)

Section 53414-9

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

Warnings

For external use only

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

Questions

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

Directions

■ For Use By Adults Only

■ Apply generously to affected area

■ Massage into painful area until thoroughly absorbed into skin.

■ Repeat as necessary, but no more than 4 times daily.

Active Ingredient

Lidocaine 4%

Inactive Ingredients

Water/Aqua/Eau, Propylene Glycol, Ethylhexyl Palmitate,Dimethicone, Stearic Acid, Hemp (Cannabis Sativa) Seed Oil, Cetearyl Alcohol, Glyceryl Stearate, PEG-100Stearate,Potassium Cetyl Phosphate, Glycerin, Lavender (Lavandula Angustifolia) Oil, Eclipta (EcliptaProstrata) Extract, Tocopheryl Acetate, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl TaurateCopolymer, Chinaberry (Melia Azadirachta) Flower Extract, Neem (Melia Azadirachta) Leaf Extract,Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Isohexadecane, Ivy Gourd (Coccinia Indica)Fruit Extract, Ethylhexylglycerin, Hexylene Glycol, Coral Weed (Corallina Officinalis) Extract, Allantoin,English/Roman Chamomile (Chamaemelum Nobile) Flower Extract, Lavender (Lavandula Angustifolia)Flower Extract, Cocoa (Theobroma Cacao) Seed Butter, Polysorbate 80, Disodium EDTA, Sodium Hydroxide,Aloe (Aloe Barbadensis) Flower Extract, Eggplant (Solanum Melongena) Fruit Extract, Moringa OleiferaSeed Oil, Melatonin, Turmeric (Curcuma Longa) Root Extract, Basil (Ocimum Basilicum) Flower/LeafExtract, Tulsi (Ocimum Sanctum) Leaf Extract, Kava (Piper Methysticum) Root Extract


Structured Label Content

Uses

For the temporary relief of pain

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.

■ do not use in large quantities, particularly over raw surfaces or blistered areas.

Section 51945-4 (51945-4)

​Hempvana

Ultra Strength

Pain Relief

Cream

Lidocaine 4%

Overnight

Calming Scent of Lavender

+ Hemp Seed Oil

For Moisturization

Net Wt. 3oz (85 g)

Section 53414-9 (53414-9)

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

Purpose

Lidocaine 4%...... Topical Analgesic

Warnings

For external use only

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

Questions

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

Directions

■ For Use By Adults Only

■ Apply generously to affected area

■ Massage into painful area until thoroughly absorbed into skin.

■ Repeat as necessary, but no more than 4 times daily.

Active Ingredient

Lidocaine 4%

Inactive Ingredients

Water/Aqua/Eau, Propylene Glycol, Ethylhexyl Palmitate,Dimethicone, Stearic Acid, Hemp (Cannabis Sativa) Seed Oil, Cetearyl Alcohol, Glyceryl Stearate, PEG-100Stearate,Potassium Cetyl Phosphate, Glycerin, Lavender (Lavandula Angustifolia) Oil, Eclipta (EcliptaProstrata) Extract, Tocopheryl Acetate, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl TaurateCopolymer, Chinaberry (Melia Azadirachta) Flower Extract, Neem (Melia Azadirachta) Leaf Extract,Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Isohexadecane, Ivy Gourd (Coccinia Indica)Fruit Extract, Ethylhexylglycerin, Hexylene Glycol, Coral Weed (Corallina Officinalis) Extract, Allantoin,English/Roman Chamomile (Chamaemelum Nobile) Flower Extract, Lavender (Lavandula Angustifolia)Flower Extract, Cocoa (Theobroma Cacao) Seed Butter, Polysorbate 80, Disodium EDTA, Sodium Hydroxide,Aloe (Aloe Barbadensis) Flower Extract, Eggplant (Solanum Melongena) Fruit Extract, Moringa OleiferaSeed Oil, Melatonin, Turmeric (Curcuma Longa) Root Extract, Basil (Ocimum Basilicum) Flower/LeafExtract, Tulsi (Ocimum Sanctum) Leaf Extract, Kava (Piper Methysticum) Root Extract


Advanced Ingredient Data


Raw Label Data

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