Terrafreeze Pain Relief Cream

Terrafreeze Pain Relief Cream
SPL v2
SPL
SPL Set ID 81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677
Route
TOPICAL
Published
Effective Date 2017-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg) Salicylic Acid (0.5 mg) Histamine
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Ascorbic Acid Indian Frankincense Bromelains Butylene Glycol C13-14 Isoparaffin Matricaria Chamomilla Citric Acid Monohydrate Turmeric Emu Oil Ethylhexylglycerin Ethylhexyl Stearate Licorice Sunflower Oil Laureth-7 Magnesium Sulfate, Unspecified Dimethyl Sulfone Niacin Phenoxyethanol Polysorbate 80 Potassium Sorbate Edetate Sodium .alpha.-tocopherol Acetate Trideceth-6 Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-12

Description

Menthol 10.00% Methyl Salicylate 10.00% Histamine DHCl 0.050%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 10.00% Methyl Salicylate 10.00% Histamine DHCl 0.050%

Uses:

For the temporary relief of minor aches and pains of the muscles and joints associated with arhritis, simple backache, sprains, bruises and strains.

Warnings:
  • For External use only
  • Keep out of reach of children. If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
Directions
  •   Apply to affected area 3-4 times daily. Adults and children two-years of age or older:
  •   Consult a physician Children under two-years of age:
Drug Facts

Other Information
  • Store at room temperature with lid closed tightly.
Other Ingredients

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, AScorbic Acid (Vitamin C), Bosewellia Serrata Extract, Bromelain, Butylene Glycol, C13-14 Isoparaffin, Chamomilla Recutta (Chamomile) Extract, Citric Acid, Curcuma Longa (Turmeric) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Laureth-7, magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Tricedeth-6, Zingiber Officinale (Ginger) Root Extract

Package Labeling:

Active Ingredients

Menthol 10.00%

Methyl Salicylate 10.00%

Histamine DHCl 0.050%

Questions Or Comments?

(support email address) or Call 1.855.977.0726

When Using This Product
  • Avoid contact with eyes.  If product gets into eyes, rinse thoroughly with water
  • Do not bandage tightly
If Pregnant Or Breastfeeding,

ask a healthcare professional before use.

Stop Use and Ask A Doctor If:
  • Rash appears
  • If symptoms persist for more than seven days, discontinue use and consult physician
Keep Out of Reach of Children.

If swallowed get medical help or contact Poison Control Center right away.


Structured Label Content

Uses:

For the temporary relief of minor aches and pains of the muscles and joints associated with arhritis, simple backache, sprains, bruises and strains.

Purpose

Topical Analgesic

Warnings:
  • For External use only
  • Keep out of reach of children. If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
Directions
  •   Apply to affected area 3-4 times daily. Adults and children two-years of age or older:
  •   Consult a physician Children under two-years of age:
Drug Facts

Other Information
  • Store at room temperature with lid closed tightly.
Other Ingredients

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, AScorbic Acid (Vitamin C), Bosewellia Serrata Extract, Bromelain, Butylene Glycol, C13-14 Isoparaffin, Chamomilla Recutta (Chamomile) Extract, Citric Acid, Curcuma Longa (Turmeric) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Laureth-7, magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Tricedeth-6, Zingiber Officinale (Ginger) Root Extract

Package Labeling:

Active Ingredients

Menthol 10.00%

Methyl Salicylate 10.00%

Histamine DHCl 0.050%

Questions Or Comments? (Questions or Comments?)

(support email address) or Call 1.855.977.0726

When Using This Product (When using this product)
  • Avoid contact with eyes.  If product gets into eyes, rinse thoroughly with water
  • Do not bandage tightly
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a healthcare professional before use.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Rash appears
  • If symptoms persist for more than seven days, discontinue use and consult physician
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed get medical help or contact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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