L'bri Stop The Pain Super Aloe Pain Relief Cream

L'bri Stop The Pain Super Aloe Pain Relief Cream
SPL v4
SPL
SPL Set ID 62e18a37-c0db-4b1e-a6a1-35684cc00e08
Route
TOPICAL
Published
Effective Date 2023-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg) Salicylic Acid (100 mg)
Inactive Ingredients
Magnesium Sulfate, Unspecified Form Apple Peppermint Oil Dimethyl Sulfone Peg-100 Stearate Phenoxyethanol Polysorbate 20 Rosemary Stearic Acid Symphytum X Uplandicum Leaf .alpha.-tocopherol Acetate Trolamine Ginger Allantoin Aloe Vera Leaf Water Arnica Montana Flower Calendula Officinalis Flower Medium-chain Triglycerides Capsaicin Carbomer Homopolymer, Unspecified Type Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Ethylhexylglycerin Eucalyptus Oil Acai Glucosamine Sulfate Glycerin Glyceryl Monostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-19

Description

Menthol 5.00% Methyl Salicylate 10.00%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 5.00% Methyl Salicylate 10.00%

Uses:

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

Warnings:

For external use only.

Do Not Use
  • on damaged or broken skin.
Drug Facts:

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.
Package Labeling:

Active Ingredients

Menthol 5.00%

Methyl Salicylate 10.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

a-Bisabolol, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Capsaicin, Carbomer, Cetearyl Alcohol, Ceteareth-20, Ethylhexylglycerin, Eucalyptus Globulus Oil, Euterpe Oleracea (Acai Berry) Fruit Extract, Glucosamine sulfate, Glycerin, Glyceryl Stearate, Magnesium Sulfate, Malus Domestica (Apple) Fruit Cell Culture Extract, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Stearic Acid, Symphytum Offiinale (Comfrey) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine, ZIngiber Officinalis (Ginger) Extract.

When Using This Product
  • Do not bandage tightly.
  • Avoid Contact with eyes.
Stop Use and Ask A Doctor If

rash or irritation develops and lasts. condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses:

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

Purpose

Topical Analgesic

Warnings:

For external use only.

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts: (DRUG FACTS:)

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.
Package Labeling:

Active Ingredients

Menthol 5.00%

Methyl Salicylate 10.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

a-Bisabolol, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Capsaicin, Carbomer, Cetearyl Alcohol, Ceteareth-20, Ethylhexylglycerin, Eucalyptus Globulus Oil, Euterpe Oleracea (Acai Berry) Fruit Extract, Glucosamine sulfate, Glycerin, Glyceryl Stearate, Magnesium Sulfate, Malus Domestica (Apple) Fruit Cell Culture Extract, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Stearic Acid, Symphytum Offiinale (Comfrey) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine, ZIngiber Officinalis (Ginger) Extract.

When Using This Product (When using this product)
  • Do not bandage tightly.
  • Avoid Contact with eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash or irritation develops and lasts. condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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


Advanced Ingredient Data


Raw Label Data

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