Otc - Active Ingredient
Camphor (3.1%)
Sierrasil
FDA Label NDC 50802-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sierra Mountain Minerals Inc. D/b/a Sierra Sil Health Inc. for the product Sierrasil (NDC 50802-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External analgesic
Indications & Usage
Uses:
Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Warnings
FOR EXTERNAL USE ONLY
Otc - Do Not Use
Do not use for arthritis-like conditions in children under 2
Do not use with a heating pad
Do not apply to wounds, damaged, broken or irritated skin
Otc - When Using
When using this product, use only as directed
Do not bandage tightly
Avoid contact with eyes and mucous membranes
Otc - Ask Doctor
Stop and ask doctor if conditions worsens, symptoms last for more than 7 days, or symptoms clear up and come back in a few days
Otc - Pregnancy Or Breast Feeding
Pregnant women should consult their physician before use
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
Adults and children 2 yrs of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 yrs of age: Do not use, consult a doctor.
Inactive Ingredient
Aloe vera oil, Eucalyptus oil, Lavender oil, Lemon oil, Orange oil, Peppermint oil, Rosemary oil, and SierraSil
Otc - Questions
Questions?
Visit www.sierrasil.com or call toll free 1-877-743-7720
Storage And Handling
Shake well before use
Package Label.Principal Display Panel
Sierra Sil
Pain Relief
Health You Can Feel
Temporarily relieves minor aches and pains
Product of USA
Manufactured under US patent number 6,444,238 B1 by Swiss Medica Inc.
Distributed by SierraSil Health Inc., Vancouver, B.C. V6J 4Z6 Canada
* Please review the disclaimer below.
