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Silvera Pain Relief Patch

Dosage form: patch
Ingredients: CAPSAICIN 0.0375g in 100g, LIDOCAINE 1g in 100g, MENTHOL 5g in 100g
Labeler: Home Aide Diagnostics, Inc.
NDC Code: 69379-037

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.

Silvera External Pain Relief Patch

ACTIVE INGREDIENTS

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

USES

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

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 AND ASK A DOCTOR IF

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than seven days

KEEP OUT OF REACH OF CHILDREN

  • If swallowed, get medical help or contact a poison control center right away

IF PREGNANT OR BREAST-FEEDING

  • Ask a healthcare professional before use

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 INGREDIENTS

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

  • FOR EXTERNAL USE ONLY
  • Use only as directed
SILVERA PAIN RELIEF PATCH 
silvera pain relief patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69379-037
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.0375 g  in 100 g
LIDOCAINE (LIDOCAINE) LIDOCAINE1 g  in 100 g
MENTHOL (MENTHOL) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BORNEOL 
Packaging
#Item CodePackage Description
1NDC:69379-037-205 PACKAGE in 1 BOX
13 PATCH in 1 PACKAGE
1100 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/28/2015
Labeler - Home Aide Diagnostics, Inc. (783518983)

Revised: 05/2015
 
Home Aide Diagnostics, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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