SILVERA PAIN RELIEF PATCH patch

Silvera Pain Relief Patch by

Drug Labeling and Warnings

Silvera Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Home Aide Diagnostics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69379-037
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BORNEOL (UNII: M89NIB437X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69379-037-20	5 in 1 BOX
1		3 in 1 PACKAGE
1		100 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/28/2015

Labeler - Home Aide Diagnostics, Inc. (783518983)