Otc - Active Ingredient
Active Ingredients Purpose
Methyl Salicylate 20% Topical Analgesic
Menthol 5% Topical Analgesic
Camphor 4% Topical Analgesic
Capsaicin.1% Topical Analgesic
Pain Relief Cream Extra Strength
FDA Label NDC 72982-1901
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Everyday Medical Llc for the product Pain Relief Cream Extra Strength (NDC 72982-1901). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
temporarily relieves minor pain associated with
- arthritis
- simple backache
- muscle strains
- bruises
- sprains
- cramps
Warnings
Warnings
For external use only
When using this product: Use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged, broken or irritated skin
- if severe burning sensation occurs, discontinue use immediately
- condition worsens
- redness is present
- irritation develops
Stop use and ask a doctor if
Otc - 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
Dosage & Administration
- Use only as directed
- Adults and children 12 years of age and older apply to affected area not more than 3 to 4 times daily
- Children under the age of 12 years of age consult a doctor
Inactive Ingredient
- Comfrey extract
- Arnica extract
- Boswellia serrata extract
- Emu oil
- Linseed oil
- Curcumin
- Vitamin E acetate oil
- Cetomacrogol 1000
- Ceto steryl alcohol
- Carbopol 2020
- Light liquid parafin
- White soft paraffin
- BHA
- BHT
- Glyceryl mono stearate
- Sodium meta bisulphate
- Simethicone
- Purified water
Package Label.Principal Display Panel
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