Label: SILVERA PAIN RELIEF PATCH patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 28, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • PRINCIPAL DISPLAY PANEL

    OTCbox.jpg

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    • Capsaicin 0.0375% - Topical Analgesic
    • Menthol 5% - External Analgestic
    • Lidocaine 1% - Topical Analgesic
  • INDICATIONS & USAGE

    USES

    • For relief of muscle aches and pains as well as:
    • Arthritis
    • Backaches
    • Strains
    • Sprains
  • WARNINGS

    WARNINGS

    • Do not get into eyes or on mucous membranes
    • Do not apply to wounds, damaged or irritated skin
    • Do not bandage or cover with any type of wrap except clothing
    • Do not use with a heating pad or apply external heat
    • Do not use in large quantities, particularly over raw surfaces or blistered areas
    • This product may cause allergic reaction in some individuals
  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • Condition worsens
    • Severe skin irritation occurs
    • Pain persists for more than seven days
  • 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
  • PREGNANCY OR BREAST FEEDING

    IF PREGNANT OR BREAST-FEEDING

    • Ask a healthcare professional before use
  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • Store below 25 oC (77 oF). Avoid direct sunlight
    • Clean and dry affected area
    • Remove patch from backing and apply to affected area
    • Use only one patch at a time and maximum of four patches daily
    • Leave patch on affeted area for up to 8-hours
    • Do not use patch for longer than 5 consecutive days unless directed by a physician
    • Children under 12 years of age should consult a physician prior to use
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    • Water
    • Pvpk-90
    • tartaric acid
    • NP-700
    • Aluminium hydroxide
    • EDTA2Na
    • Titanium dioxide
    • Glycerin
    • Pvpp
    • Alcohol borneol
    • Camphor
  • PURPOSE

    • FOR EXTERNAL USE ONLY
    • Use only as directed
  • INGREDIENTS AND APPEARANCE
    SILVERA PAIN RELIEF PATCH 
    silvera pain relief patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69379-037
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE1 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BORNEOL (UNII: M89NIB437X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69379-037-205 in 1 BOX
    13 in 1 PACKAGE
    1100 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/28/2015
    Labeler - Home Aide Diagnostics, Inc. (783518983)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!