Ted's Brain Science Products Pain Cream

Ted's Brain Science Products Pain Cream
SPL v2
SPL
SPL Set ID 849d6e28-a6c1-7f49-e053-2a91aa0a497d
Route
TOPICAL
Published
Effective Date 2019-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Cetearyl Olivate Ethylhexylglycerin Glycerin Glyceryl Stearate Se Peg-100 Stearate Phenoxyethanol Polysorbate 20 Dimethyl Sulfone Arnica Montana Flower Cetyl Alcohol Water Resveratrol Sodium Lauryl Glycol Carboxylate Sodium Hydroxypropylsulfonate Laurylglucoside-7 Crosspolymer Sorbitan Olivate Stearic Acid Boswellia Serrata Resin Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-21

Description

Methyl Salicylate - 10%

Purpose

Topical Pain Relief


Medication Information

Purpose

Topical Pain Relief

Description

Methyl Salicylate - 10%

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruises and • sprains

Warnings

For external use only​

Directions

Use only as directed​

adults and children 2 years of age and older:

  • apply to affected area not more than 3 or 4 times daily

children under 2 years of age: consult a physician

Do Not Use
  • on wounds or damaged skin
  • with a heating pad
Allergy Alert

If you had prior allergic reaction to aspirin or salicylate, please consult a physician before use.

Package Labeling

Active Ingredient

Methyl Salicylate - 10%

Other Information

Store at 20ºC to 25ºC (68ºF - 77ºF)

Inactive Ingredients:

Aqua (deionized water), Arnica Montana (arnica) Extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, PEG-100 stearate, phenoxyethanol, polysorbate 20, resveratrol, sodium laurylglucosides, hydroxypropylsulfonate, sorbitan olivate, stearic acid

When Using This Product

• use only as directed • avoid contact with eyes and muscous membranes • do not bandage tightly

Ask A Physician Before Use If
  • you have redness over the affected area
Stop Use and Ask A Physician If

• condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occurs • pregnant or breast-feeding

Keep Out of Reach of the Children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruises and • sprains

Purpose

Topical Pain Relief

Warnings

For external use only​

Directions

Use only as directed​

adults and children 2 years of age and older:

  • apply to affected area not more than 3 or 4 times daily

children under 2 years of age: consult a physician

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
Allergy Alert

If you had prior allergic reaction to aspirin or salicylate, please consult a physician before use.

Package Labeling

Active Ingredient (Active ingredient)

Methyl Salicylate - 10%

Other Information

Store at 20ºC to 25ºC (68ºF - 77ºF)

Inactive Ingredients: (Inactive ingredients:)

Aqua (deionized water), Arnica Montana (arnica) Extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, PEG-100 stearate, phenoxyethanol, polysorbate 20, resveratrol, sodium laurylglucosides, hydroxypropylsulfonate, sorbitan olivate, stearic acid

When Using This Product (When using this product)

• use only as directed • avoid contact with eyes and muscous membranes • do not bandage tightly

Ask A Physician Before Use If (Ask a physician before use if)
  • you have redness over the affected area
Stop Use and Ask A Physician If (Stop use and ask a physician if)

• condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occurs • pregnant or breast-feeding

Keep Out of Reach of the Children (Keep out of reach of the children)

In case of accidental ingestion, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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