Hempvana Cold As Ice Pain Relief Gel-patch

Hempvana Cold As Ice Pain Relief Gel-patch
SPL v2
SPL
SPL Set ID 976a1bb2-b776-8199-e053-2995a90a1a1b
Route
TOPICAL
Published
Effective Date 2019-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Water Dihydroxyaluminum Aminoacetate Glycerin Kaolin Methylparaben Polyacrylic Acid (250000 Mw) Polysorbate 80 Povidone Propylene Glycol Propylparaben Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-15

Description

Menthol 5%

Purpose

Menthol 5%................Topical Anesthetic


Medication Information

Purpose

Menthol 5%................Topical Anesthetic

Description

Menthol 5%

Uses

temporarily relief of pain

Section 44425-7
  • Avoid storing patches in direct sunlight. Protect patches from excessive moisture
Section 50565-1

Keep out of reach of children and pets.If ingested, 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
Section 50570-1

Do not use

  • more than one patch at a time
  • on wounds, cuts, damaged, broken and/or irritated skin
  • over raw surfaces or blistered areas
  • at the same time as other topical analgesics
  • if allergic to menthol or any inactive ingredients
  • if package is damaged or opened
Section 51945-4

Section 53414-9

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

Warnings

For external use only

Directions

Adults and children over 12 years of age

  • Clean and dry affected area
  • follow application insructions above to apply patch to skin
  • Apply one patch to affected area no more than 3-4 times daily
  • Remove patch from affected area after maximum of 8 hour application
  • Children uner 12 years of age: consult a doctor
Drug Facts

Questions?

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

Active Ingredient:

Menthol 5%

Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium polyacrylate,Tartaric Acid, Titanium Dioxide, Water


Structured Label Content

Uses

temporarily relief of pain

Section 44425-7 (44425-7)
  • Avoid storing patches in direct sunlight. Protect patches from excessive moisture
Section 50565-1 (50565-1)

Keep out of reach of children and pets.If ingested, 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
Section 50570-1 (50570-1)

Do not use

  • more than one patch at a time
  • on wounds, cuts, damaged, broken and/or irritated skin
  • over raw surfaces or blistered areas
  • at the same time as other topical analgesics
  • if allergic to menthol or any inactive ingredients
  • if package is damaged or opened
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Menthol 5%................Topical Anesthetic

Warnings

For external use only

Directions

Adults and children over 12 years of age

  • Clean and dry affected area
  • follow application insructions above to apply patch to skin
  • Apply one patch to affected area no more than 3-4 times daily
  • Remove patch from affected area after maximum of 8 hour application
  • Children uner 12 years of age: consult a doctor
Drug Facts

Questions?

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

Active Ingredient:

Menthol 5%

Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium polyacrylate,Tartaric Acid, Titanium Dioxide, Water


Advanced Ingredient Data


Raw Label Data

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