Otc - Active Ingredient
Camphor 6%, Menthol 16%
Outback Pain Relief Cream
FDA Label NDC 72839-987
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Care Research Labs, Llc for the product Outback Pain Relief (NDC 72839-987). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, 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
For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.
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 or mucous membranes, and do not apply to wounds or damaged skin. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding ask a health professional.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 12 years of age and older apply generously to the affected area not more than 4 times daily. Children under 12 years of age: ask a doctor.
Inactive Ingredient
Benzyl Alcohol, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylamide, Sorbitan Olivate, Tocopherol, Vanilla Planifolia Fruit Extract, Water.
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