FDA Label for Topical Pain Relief
View Indications, Usage & Precautions
Topical Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Two Hip Consulting, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients PurposeMethyl salicylate 20% (16gm) Topical AnalgesicMenthol 5% (4gm) Topical AnalgesicCapsaicin 0.035% (0.3gm) Topical Analgesic
Otc - Purpose
For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness. This product does not cure any diseases.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
Discontinue use and consult a physician if condition worsens or irritation develops. Pain persists for more than 7 days. If pain clears up and then redevelops.
Warnings
Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor.
Do not use: on cuts or infected skin, on children less than 12 years old, in combination with other topical pain products, if allergic to any ingredients, PABA, aspirin products, or sulfa. Do not use if you are pregnant or nursing. Store below 90 degrees F/32 degrees C. See USP Controlled Temperature.
Dosage & Administration
Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.
Inactive Ingredient
Inactive Ingredients: Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, sodium Hydroxide, Stearyl Alcohol, Water.
Package Label.Principal Display Panel
Medi-Derm
120gm (4 fl oz)
Topical pain relief cream
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