SILVERA PAIN RELIEF PATCH- silvera pain relief patch patch 
Home Aide Diagnostics, Inc.

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.

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Silvera External Pain Relief Patch

OTCbox.jpg

ACTIVE INGREDIENTS

USES

WARNINGS

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

IF PREGNANT OR BREAST-FEEDING

DIRECTIONS

INACTIVE INGREDIENTS

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)

Revised: 5/2015
Document Id: 17261c31-21ab-5e21-e054-00144ff88e88
Set id: 17261c31-21aa-5e21-e054-00144ff88e88
Version: 1
Effective Time: 20150528
 
Home Aide Diagnostics, Inc.