SILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]

SILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]
PDF | XML

NDC 69379-037-20
Set ID 17261c31-21aa-5e21-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Home Aide Diagnostics, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • 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)

Related Drugs