Active Ingredients
Active Ingredients Purpose
Menthol _______________________________ 2.0% Topical Analgesic
Camphor ______________________________ 8.0% Topical Analgesic
Methyl Salicylate_________________________ 8.0% Topical Analgesic
Doloran
FDA Label NDC 71016-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hector Rivera Garzon Y Compania. S. En C. for the product Doloran (NDC 71016-001). 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 active ingredients, purpose, use, warnings, otc - keep out of reach of children, directions, 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
Purpose
Topical Analgesic
Use
Temporarily relieves the minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only
- Do not use on wounds or damaged skin with a healing pad
- Do not use on a child under 12 years of age with arthritis-like conditions
Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of htis product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly
Otc - Keep Out Of Reach Of Children
Keep out of reach of children to avoid accidental ingestion.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- Use only as directed
- Adults and children 12 years of age and older; apply to affected area not ore than 3 to 4 times daily
- Children under 12 years of age; ask a doctor
Inactive Ingredient
Inactive Ingredients (Petrolatum, anhydrous lanolin, parrafin)
Package Label.Principal Display Panel
Pdp.jpg (Pdp)
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